Who is the manufacturer of Anthogyr Surgical Cassettes?

Anthogyr filed the 510(k) submission for Anthogyr Surgical Cassettes (K230680).

What is the FDA product code for Anthogyr Surgical Cassettes?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Anthogyr Surgical Cassettes?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Anthogyr Surgical Cassettes?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Anthogyr Surgical Cassettes

K230680 · Anthogyr · KCT · Jul 11, 2023 · General Hospital

Device Facts

Record ID	K230680
Device Name	Anthogyr Surgical Cassettes
Applicant	Anthogyr
Product Code	KCT · General Hospital
Decision Date	Jul 11, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Indications for Use

The Anthogyr Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.

Device Story

Anthogyr Surgical Cassettes are reusable rigid containers used to organize, protect, and steam-sterilize dental surgical instruments. The device consists of a base, removable inner tray, and locking lid. Trays feature medical-grade silicone brackets to secure instruments and color-coded/pictogram markings to guide surgical workflows. Used in clinical dental settings by healthcare providers. The cassette is loaded with instruments (max load 412g), placed in an FDA-cleared steam sterilizable pouch, and subjected to pre-vacuum steam sterilization (132°C for 4 minutes, 20-minute dry time). The device facilitates instrument organization during procedures and ensures effective sterilization penetration via perforated design. It does not maintain sterility post-sterilization without the external pouch.

Clinical Evidence

Bench testing only. Validated for 250 reprocessing cycles (cleaning, sterilization, functional testing). Sterilization validation performed per ISO 17665-1 using pre-vacuum steam (132°C, 4 min exposure, 20 min dry). Cleaning validation (manual and automated) confirmed residual hemoglobin and protein levels below 2.2 µg/cm² and 6.4 µg/cm², respectively. Biocompatibility confirmed non-cytotoxic per ISO 10993-5.

Technological Characteristics

Materials: Polyphenylsulfone (Radel R-5000/R-5100), medical-grade silicone, stainless steel. Design: Perforated rigid plastic tray with locking lid and silicone instrument brackets. Dimensions: 130x155x47 mm or 76x155x47 mm. Sterilization: Pre-vacuum steam (132°C). Reusable (up to 250 cycles).

Indications for Use

Indicated for healthcare providers to organize, steam sterilize, and protect dental surgical drills and tools. Requires enclosure in an FDA-cleared steam sterilizable pouch. Not intended to maintain sterility independently.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

Instrument Kits (K160730)

Reference Devices

Neodent EasyGuide Kit Cases (K203618)

Submission Summary (Full Text)

{0}------------------------------------------------ July 11, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Anthogyr % Jennifer Jackson Senior Director, Regulatory & Quality NAM Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801 #### Re: K230680 Trade/Device Name: Anthogyr Surgical Cassettes Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 9, 2023 Received: June 9, 2023 #### Dear Jennifer Jackson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerelv. Image /page/1/Picture/5 description: The image shows a digital signature for Eileen Cadel. The signature includes the name "Eileen Cadel" on the left side of the image. On the right side, it states that the signature is "Digitally signed by Eileen Cadel" and includes the date and time of the signature: "2023.07.11 14:44:58 -04'00'". Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K230680 Device Name Anthogyr Surgical Cassettes #### Indications for Use (Describe) The Anthogyr Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility. The cycle of sterilization is: INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V, INMODIGMV: Pre-vacuum steam: 132 ℃ (270°F) during 4 minutes with 20 minutes drying time The Anthogyr Surgical Cassettes have been validated for a maximum load of with the associated instruments: The worst-case recommended load is 412g. The device dimensions are listed below for Anthogyr Surgical Cassettes: - INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3V: 130x155x47 mm - INMODIGM, INMODIGMV: 76x155x47 mm The cassettes are not intended to be stacked during sterilization process. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## Anthogyr Surgical Cassettes 510(k) Summary ## 510(k) Summary ### Submitter's Contact Information | Submitter: | Straumann USA, LLC (on behalf of Anthogyr) 60 Minuteman Road Andover, MA 01810 Registration No.: 1222315 Owner/Operator No.: 9005052 On the behalf of: Anthogyr 2237 Av. André Lasquin, 74700 Sallanches, France | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jennifer M. Jackson, MS, RAC Senior Director, Regulatory Affairs & Quality NAM Phone Number: +1 978 747-2509 Fax Number: +1 978 747-0023 | | Prepared By & Alternate Contact: | Aude GOULET Regulatory Affairs Project Manager Anthogyr Phone number: +33450580237 | | Date of Submission: | July 10, 2023 | #### Name of the Device | Trade Names: | Anthogyr Surgical Cassettes | |------------------------|---------------------------------------------------------------------| | Common Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | | Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | | Regulation Number: | 21 CFR 880.6850 | | Device Classification: | II | | Product Code(s): | KCT | | Classification Panel: | General Hospital | | Proprietary Name | Anthogyr Surgical Cassettes | {4}------------------------------------------------ ## Anthogyr Surgical Cassettes 510(k) Summary #### Predicate Device(s) Primary Predicate: - K160730 Instrument Kits (Anthogyr) . | Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | |------------------------|---------------------------------------------------------------------| | Regulation Number: | 21 CFR 880.6850 | | Device Classification: | II | | Product Code(s): | KCT | Reference Devices: - K203618 Neodent EasyGuide Kit Cases (JJGC Indústria e Comércio de Materiais . Dentários SA) | Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | |------------------------|---------------------------------------------------------------------| | Regulation Number: | 21 CFR 880.6850 | | Device Classification: | II | | Product Code(s): | KCT | #### Device Description Anthogyr Surgical Cassettes are reusable rigid containers, comprising a case bottom (base), one or more removable inner tray base (tray) and a tray lid (lid). The trays are composed of brackets made of medical grade silicone, namely brackets used to maintain the Anthogyr dental instruments in place during the surgical or prosthetic procedure and during sterilization. The base and trays have markings and/or colors code to indicate either the surgical workflow, or the position of the instruments in the kit. The lid holds all the instruments securely in place during treatment. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Anthogyr Dental Implant System intended to be placed in the Anthogyr Surgical Cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Anthogyr Dental Implant System. These devices are all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR {5}------------------------------------------------ ### Anthogyr Surgical Cassettes 510(k) Summary 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission. #### Intended Use Anthogyr cassettes are intended to organize instruments, and secure instruments during the sterilization phase. #### Indications for Use The Anthogyr Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility. The cycle of sterilization is: INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V, INMODIGMV: Pre-vacuum steam: 132 °C (270° F) during 4 minutes with 20 minutes drying time The Anthogyr Surgical Cassettes have been validated for a maximum load of with the associated instruments: The worst-case recommended load is 412g. The device dimensions are listed below for Anthogyr Surqical Cassettes: - INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3, INMODOPP3V: 130x155x47 mm - INMODIGM, INMODIGMV: 76x155x47 mm The cassettes are not intended to be stacked during sterilization process. #### Technological Characteristics The subject devices and predicate devices K160730 and K203618 share the following characteristics: - . ldentical indications for use - ldentical Product code . - . Identical Design {6}------------------------------------------------ ### Anthogyr Surgical Cassettes 510(k) Summary - Identical Material ● - Identical Materials compatible with sterilization method . - . Identical Perforated - Identical Reusable ● - . Identical Sterilization Method - . Identical Cycles - Identical Parameters - ldentical Sterile Barrier ● - . Identical Biocompability - . Equivalent vent to volume The difference between the primary predicate device with the Anthogyr Surgical Cassettes subject devices are in the Table 1: | | Number of brackets in the cassette | |---------------------------------------------|------------------------------------| | Primary Predicate Device: (K160730) | 33 | | Subject devices: INMODOPS3L/ INMODOPS3LV | 37 | | Subject devices: INMODOPS3/ INMODOPS3V | 37 | | Subject devices: INMODOPP3/ INMODOPP3V | 21 | | Subject devices: INMODIGM/ INMODIGMV | 12 | Table 1 – Difference between the primary predicate device with the Anthogyr Surgical Cassettes subject devices The technological characteristics of the subject devices are compared to the primary predicate and reference device in the Table 2. {7}------------------------------------------------ # Anthogyr Surgical Cassettes #### 510(k) Summary | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FEATURE | K230680 | K160730 | K203618 | Equivalence discussion | | | Anthogyr Surgical Cassettes | Instrument Kits | Neodent EasyGuide Kit Cases | | | Indications for Use | The Anthogyr Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility. The cycle of sterilization is: INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V, INMODIGMV: Pre-vacuum steam: 132 °C (270° F) during 4 minutes with 20 minutes drying time The Anthogyr Surgical Cassettes have been validated for a maximum load of with the associated instruments: The worst-case recommended load is 412g. The device dimensions are listed below for Anthogyr Surgical Cassettes: - INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3, INMODOPP3V: 130x155x47 mm - INMODIGM, INMODIGMV: 76x155x47 mm The cassettes are not intended to be stacked during sterilization process. | The instrument kits are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility. | Indications for Use for GM EasyGuide Surgical Kit Case Narrow/Regular Diam Implants: Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kits require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The Kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20-minute dry time. Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time. Neodent Instrument Kits are intended for sterilization of non-porous loads. The combined weight of the GM EasyGuide Surgical Kit Case Narrow/Regular Diam Implants and the associated instruments is 310,18 g. The weight of the empty Kit Case is 263,63 g. Neodent GM EasyGuide Kit Cases should not be stacked during sterilization Indications for Use for GM EasyGuide Surgical Kit Case Regular/Large Diam Implants: Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow | Identical The subject devices have the same indications for use as the primary predicate. More detail regarding the indication like weight and sterilization condition were added. | | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | | | FEATURE | K230680 | K160730 | K203618 | Equivalence discussion | | | Anthogyr Surgical Cassettes | Instrument Kits | Neodent EasyGuide Kit Cases | | | | | | sterilization of the enclosed medical devices. Neodent Instrument Kits require the use of FDA- cleared wrap to maintain the sterility of the enclosed devices. The Kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry time. Gravity displacement - Exposure at 132 °C for 15 minutes, 45-minute dry time. Neodent Instrument Kits are intended for sterilization of non-porous loads. The combined weight of the GM EasyGuide Surgical Kit Case Regular/Large Diam Implants | | | | | | and the associated instruments is 346,45 g. The weight of the empty Kit Case is 264,12g. Neodent EasyGuide Kit Cases should not be stacked during sterilization. | | | Product code | KCT | KCT | KCT | Identical The subject devices have the same product code as the primary predicate and reference devices. | | Design | Plastic tray with locking lid and silicone containments brackets | Plastic tray with locking lid and silicone containments brackets | Rigid base and removable inner tray with a lid. Retention grommets. | Identical The subject devices have the same design as the primary predicate. | | Dimensions | INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3, INMODOPP3V: 130x155x47 mm INMODIGM, INMODIGMV: 76x155x47 mm | 130x155x47 mm 76x155x47 mm | 195x90x 64 mm | Identical The subject devices have the same dimensions as the primary predicate. | | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | Equivalence discussion | | FEATURE | K230680 | K160730 | K203618 | | | | Anthogyr Surgical Cassettes | Instrument Kits | Neodent EasyGuide Kit Cases | | | Materials | Polyphenylsulfone (Radel R-5000) Polyphenylsulfone (Radel R-5100) Medical grade silicone Stainless steel | Polyphenylsulfone (Radel R-5000) Polyphenylsulfone (Radel R-5100) Medical grade silicone Stainless steel | Polysulfone polymer Polyphenylsulfone Medical grade silicone | Identical The subject devices have the same materials as the primary predicate. | | Materials compatible with sterilization Method | Yes | Yes | Yes | Identical The subject devices have the same materials compatible with sterilization method as the primary predicate and reference devices. | | Perforated | Yes; allows moist heat (steam) penetration to achieve sterilization | Yes; allows moist heat (steam) penetration to achieve sterilization | Yes; allows moist heat (steam) penetration to achieve sterilization | Identical The subject devices have the same perforated as the primary predicate. | | Reusable | Yes, up to 250x | Yes, up to 250x | Yes, up to 100x | Identical The subject devices have the same reusable life as the primary predicate. | | Sterilization Method | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6…

Anthogyr Surgical Cassettes

Device Facts

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Device Story

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Technological Characteristics

Indications for Use

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Submission Summary (Full Text)

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Anthogyr Surgical Cassettes

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Indications for Use

Device Story

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Indications for Use

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Reference Devices

Submission Summary (Full Text)

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