← Product Code [ELW](/productcode/ELW) · K143575 # Accu-Dent XD Tray, Accu-Dent XD Syringe (K143575) _Ivoclar Vivadent, Inc. · ELW · Apr 3, 2015 · Dental · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K143575 ## Device Facts - **Applicant:** Ivoclar Vivadent, Inc. - **Product Code:** [ELW](/productcode/ELW.md) - **Decision Date:** Apr 3, 2015 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 872.3660 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use The Accu-Dent XD impression materials are recommended for use to create highly detailed impressions of the hard and soft tissues of the oral cavity including the following list of indications: Complete and partial denture impressions Opposing models for fixed and removable prosthesis Study Model Temporary crown & Bridge impressions Whitening Trays Mouth Guards Orthodontic Impressions ## Device Story Accu-Dent XD is a two-part alginate impression system comprising a tray material and a syringe material. The clinician mixes the powders with water, loads the tray material into a preformed perforated impression tray, and loads the syringe material into a plastic delivery syringe. The syringe material is dispensed directly onto oral tissues, followed by insertion of the filled tray. The materials polymerize in the mouth to capture the dentition structure. The tray material features a chromatic color change to indicate setting. Once set, the impression is removed, disinfected, and used to pour dental stone models. The system is used in a dental clinic setting by a dentist or dental professional. The output is a physical impression used to fabricate restorative prosthetic devices, study models, or orthodontic appliances, aiding in clinical decision-making and treatment planning. ## Clinical Evidence Bench testing only. The device was evaluated against ISO 21563:2013 standards for dental hydrocolloid impression materials. Performance metrics included working time, setting time, compressive strength, tear strength, strain in compression, recovery from deformation, and gypsum compatibility. Results demonstrated compliance with ISO requirements and equivalence to predicate performance. ## Technological Characteristics Two-part alginate impression system (Tray and Syringe materials). Materials conform to ISO 21563:2013. Delivered in pre-dosed sealed pouches. Tray material exhibits chromatic color change upon setting. Manual mixing with water. Mechanical polymerization in the oral cavity. No electronic components or software. ## Regulatory Identification Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. ## Special Controls *Classification.* Class II (Special Controls). ## Predicate Devices - Tropicalgin ([K043131](/device/K043131.md)) - Neocolloid ([K981091](/device/K981091.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 3, 2015 Ivoclar Vivadent, Inc. Ms. Donna Marie Hartnett Director, OA/Regulatory Affairs 175 Pineview Drive Amherst. New York 14228 Re: K143575 Trade/Device Name: Accu-Dent® XD Regulation Number: 21 CFR 872.3660 Regulation Name: Impression material Regulatory Class: II Product Code: ELW Dated: January 2, 2015 Received: January 5, 2015 Dear Ms. Hartnett: 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. 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. {1}------------------------------------------------ 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use ## 510(k) Number (if known): K143575 ### Device Name: Accu-Dent® XD ### Indications For Use: The Accu-Dent XD impression materials are recommended for used to create highly detailed impressions of the hard and soft tissues of the oral cavity includin the following list of indications: - Complete and partial denture impressions ● - Opposing models for fixed and removable prosthesis ● - o Study Model - Temporary crown & Bridge impressions - Whitening Trays ● - Mouth Guards ● - Orthodontic Impressions o Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 {3}------------------------------------------------ Accu-Dent XD Revised April 3. 2015 Image /page/3/Picture/3 description: The image shows the logo for Ivoclar Vivadent. The logo features the company name in a stylized font, with "Ivoclar" in a lighter blue and "Vivadent" in a darker blue. Above the name are several green and blue squares and circles. Below the name is the company's slogan, "passion vision innovation," in a smaller, red font. Revised April 3, 2015 | Contact: | Donna Marie Hartnett | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company: | Ivoclar Vivadent, Inc.
175 Pineview Drive, Amherst, NY 14228
800-533-6825 | | Date Prepared: | April 3, 2015 | | Proprietary Name: | Accu-Dent ® XD | | Classification Name: | Material, Impression (872.3660)
(Classification Code ELW) | | Predicate Device: | Tropicalgin (K043131) & Neocolloid (K981091) by Zhermack sPA | | Device Description: | Accu-Dent XD is a two-part Alginate impression system intended
to be placed on a preformed impression tray and used to
reproduce the structure of a patient's teeth and gums. The device
is intended to provide impressions models for study and for
production of restorative prosthetic devices, such as full and
partial dentures. | vivade passion vision inr#### Intended Use: The Accu-Dent XD impression materials are recommended for use to create highly detailed impressions of the hard and soft tissues of the oral cavity including the following list of indications: - Complete and partial denture impressions - . Opposing models for fixed and removable prosthesis - Study Model ● - . Temporary crown & Bridge impressions - . Whitening Trays - . Mouth Guards - Orthodontic Impressions ● Comparison to Predicate: The predicate device to which Accu-Dent XD has been compared is Tropicalgin (K043131) & Neocolloid (K981091) by Zhermack sPA . Accu-Dent XD consists of a tray material (comparable to Tropicalgin) and a Syringe material (comparable to Neocolloid) which, when used together are intended to take impressions of the oral cavity. The materials have been compared based on physical properties for working time, strain in compression, recovery from deformation, tear strength, gypsum compatibility and detail reproduction. Accu-Dent XD materials have been determined to be substantially equivalent to the predicate device. {4}------------------------------------------------ Accu-Dent XD Revised April 3, 2015 Image /page/4/Picture/3 description: The image shows the logo for Ivoclar Vivadent. The logo features the company name in a stylized font, with "Ivoclar" in a smaller, lighter blue font above "Vivadent" in a larger, darker blue font. Above the company name is a semi-circular arrangement of green and blue squares, with the green squares on the left side and the blue squares on the right side. passion vision innovation | Indications | (Tropicalgin) Dental impression
material intended to be placed on
a preformed impression tray and
used to reproduce the structure
of a patient's teeth. It is also
intended to provide models for
study and for production of
restorative prosthetic devices,
such as dental inlays and
dentures.
(Neocolloid) Alginate dental
impression materials that are
intended to be used to make
dental impressions. The resulting
impressions are used to make
plaster models of then teeth. | The AccuDent XD impression materials
are recommended for use to create
highly detailed impressions of the hard
and soft tissues of the oral cavity
including the following list of indications:
• Complete and partial denture
impressions
• Opposing models for fixed and
removable prosthesis
• Study Models
• Temporary crown & bridge impressions
• Whiting Trays
• Mouth Guards
• Orthodontic Impressions | |------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Discussion The variation is not substantial and is a refinement and clarification of the
predicate's more general statement of indications. | | | {5}------------------------------------------------ Accu-Dent XD Revised April 3, 2015 Image /page/5/Picture/3 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green, with the words "Ivoclar Vivadent" in a sans-serif font. Above the words are a series of green and blue dots and squares arranged in an arc. The dots are green and the squares are blue. The logo is simple and modern. passion vision innovation | Technology | | passion vision inn | |--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Predicate device | Accu-Dent XD | | Working
principle | Neocolloid and Tropicalgin were
developed separately. | Accu-Dent XD Tray and Syringe materials
were developed to work together. | | | The powder is intended to be mixed
with water | The powder is intended to be mixed with
water | | | 18 gm powder to 36 ml water for
Tropicalgin
18 gm powder to 36 ml water for
Neocolloid | 24gm gm powder to 44 ml water for Tray
9gm powder to 21 ml water for Syringe | | | The mixed paste is loaded onto a
preformed perforated impression
tray and inserted into the mouth.
While in the mouth, the paste
polymerizes so when it is removed, it
leaves an impression of the patitent's
dentition. | The mixed syringe paste is loaded into a
plastic delivery syringe with specially
designed application tip and the material is
dispensed directly onto the oral tissue by
hand. The mixed tray paste is loaded onto
a preformed perforated impression tray and
inserted into the mouth. While in the
mouth, the paste polymerizes so when it is
removed, it leaves an impression of the
patient's dentition. | | | Tropicalgin was designed to exhibit a
chromatic color change as the
materials set. | Accu-Dent XD also has the chromatic
color change (Tray material only) as the
materials set. | | Discussion: The change in powder/water ratio has a minor impact on the physical properties | | | | Delivery forms | Neocolloid and Tropicalgin are delivered in bulk bags (500g and 453g respectively) which are scooped out by the user using a measuring spoon.

Tropicalgin is Yellow and has a Mango scent
Neocolloid is Orange and has an herbal scent | Accu-Dent XD Tray and Syringe Powers are delivered in single dose sealed pouches, 12 packages per box.

Accu-Dent XD Tray is Blue
Accu-Dent XD Syringe is Orange
Both materials will have a mild mint scent | | Discussion: | Variations in color and scent play no active role in the performance of the materials.
The new pre-dosed pouches are similar to the existing Accu-Dent materials, which have been on the market since before 1976. The packaging processes have been validated to assure adherence to the dosing specification | | | Storage conditions | 5-27 °C/41-80 °F for all items.
3 year shelf life | 5-27 °C/41-80 °F for all items.
3-year shelf life | | Discussion: | No difference | | | Principles of operation | Mix materials
Load into preformed tray
Insert into mouth and wait til set
Remove from mouth
Disinfect
Pour the impression - dental stone | Mix materials
Load Tray material into preformed tray
Load syringe material into dispensing syringe
Syringe material onto tissue
Insert filled tray into mouth and wait until set
Remove from mouth
Disinfect
Pour the impression - dental stone | of the device which is discussed below. The two-step clinical procedure has only impact on the finished impression. The color contrast provides for improved impression reading. {6}------------------------------------------------ Accu-Dent XD Revised April 3, 2015 Image /page/6/Picture/3 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green, with the words "ivoclar vivadent" in a bold, sans-serif font. Above the words are a series of green and blue dots and squares. Below the words is the tagline "passion vision innovation" in a smaller, sans-serif font. Discussion: No variation except that the Tray and Syringe materials are intended to be used together. The predicate materials were intended to be used alone. The tray and syringe materials have been tested to work together. Once inserted into the mouth, they adhere together and pose no additional safety or efficacy issues. {7}------------------------------------------------ ## 510(K) SUMMARY Accu-Dent XD Revised April 3, 2015 Image /page/7/Picture/2 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized blue font, with the words "passion vision innovation" written in a smaller font below. Above the company name, there is a series of green and blue dots and squares arranged in an arc shape. The logo is simple and modern, and it conveys a sense of innovation and professionalism. ### Technological Characteristics: | Conformity to product-
specific Standard | Predicate Device | Accu-Dent XD | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------------------------------------------|--| | Applicable standard | ADA Spec 18/ ISO 1563 | ISO 21563:2013
Dentistry: Hydrocolloid
Impression Materials | | | Applicable FDA Guidance | Dental Impression Materials
1998 | Dental Impression Materials
1998 | | | Discussion ISO 21563 is a consolidation of 3 standards relating to impression materials
including ISO 1563:1990 for Alginate impression materials. Under the new standard, the
alginate materials are now required to be subject to the same tear strength test that has
been in effect for the agar hydrocolloid impression materials (ISO 1564 and ISO 13716)
instead of being subject to a compressive strength. This is understood to be a better
performance measure. | | | | | | Predicate Device | | Accu-Dent XD | | | | |------------------------------------------------------|-----------------------------------------|--------------|------------------|----------------------------------------|------------|------------| | Characteristic | Troplicalgin | Neocolloid | Tray | Syringe | | | | Mixing Time | 45" | 45" | 45" | 45" | | | | Working Time | 1'35" | 2'00" | 1'15" | 2'00" | | | | Setting Time | 2'35" | 3'30" | 2'30" | 3'30" | | | | Time in Mouth | 1'00" | 1'30" | 30" | 45" | | | | Ratio Powder/Water | 18gm
36ml | 18gm
36ml | 24gm
44ml | 9gm
21ml | | | | Compressive
Strength | ISO
1563:
1990 | 1.362 N/mm | ISO
1563:1990 | 1.336 N/mm | .943 N/mm | | | Tear Strength | ISO
21563:
2013 | 0.647 N/mm | 0.597 N/mm | ISO
21563:2013
0.38
N/mm(min) | 0.778 N/mm | 0.504 N/mm | | Strain in
Compression
Permanent
deformation | ISO
1563:
1990
5.0% -
20.0% | 11.5% | 10.3% | ISO
21563:2013
5.0% -
20.0% | 10.0% | 14.62% | {8}------------------------------------------------ Accu-Dent XD Revised April 3, 2015 Image /page/8/Picture/3 description: The image shows the logo for Ivoclar Vivadent. The logo features the company name in two lines, with "Ivoclar" in a larger, bold blue font above "Vivadent" in a similar blue font. Above the company name is a semi-circular arrangement of green and blue dots and squares. Below the company name is the company slogan "passion vision innovation". **passion vision innovation** | Recovery from
deformation | ાડળ
1563:
1990
Min.
95.0% | 99% | 99% | ાડભ
21563:2013
Min 95.0% | 95.56% | 97.63% | |--------------------------------------------------------------------------------------------|---------------------------------------------------|----------|----------|-------------------------------------------|----------|----------| | Gypsum
Compatibility | ાટેટે
1563:
1990
Line
reprod
50 um | complies | complies | ાડભ
21563:2013
Line reprod
50 µm | Complies | complies | | Discussion: The primary change from the predicate is the powder/water ratio for the mixed | | | | | | | alginate. This change impacts the physical properties, but not in a significant manner. The most notable change is the difference in the Recovery from deformation results. Although lower, the result remains within the acceptance criteria of the ISO 21563 and ISO 1563 of minimum 95%. Therefore, there is no expectation that the clinical outcome of the impression or the ultimate restoration will be affected. Guidance Document: This submission follow the requirements set out in FDA Guidance Document entitled Dental Impression Materials - Premarket Notification dated August 17, 1998. CONCLUSION: The above data and analysis demonstrates that Accu-Dent XD is substantially equivalent to the predicate device. --- **Source:** [https://fda-staging.innolitics.com/device/K143575](https://fda-staging.innolitics.com/device/K143575) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com