← Product Code [ELC](/productcode/ELC) · K991239 # VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2 (K991239) _Micron Corp. · ELC · Oct 18, 1999 · Dental · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K991239 ## Device Facts - **Applicant:** Micron Corp. - **Product Code:** [ELC](/productcode/ELC.md) - **Decision Date:** Oct 18, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.4850 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use The VIP 60 is an instrument of calculus and plaque removal which the dentist uses for dental treatment. This VIP 60 is used with scaling tips and a coolant water spray for debriding to heavy calculus and plaque deposits from tooth and root surfaces. ## Device Story VIP 60 is an air-powered dental scaler used by dentists for debridement of calculus and plaque. Device connects directly to a dental handpiece hose; utilizes scaling tips and coolant water spray. Operates via mechanical vibration to remove deposits from tooth and root surfaces. Thin tip design allows access to subgingival pockets, interdental areas, and molar furcations; provides tactile feedback to operator regarding calculus adherence. Benefits include reduced patient pain, bleeding, and irritation compared to ultrasonic scalers; allows precise manipulation to avoid hypersensitive areas. Designed for repeated sterilization. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Air-powered dental scaler; mechanical vibration principle. Features thin scaling tips for subgingival access. Includes coolant water spray delivery system. Designed for repeated sterilization. Standalone device connecting to standard dental handpiece hoses. ## Regulatory Identification An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth. ## Predicate Devices - KAVO AMERICA'S SONICFLEX ## 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}------------------------------------------------ OCT 1 8 1999 K991239 # 510 (k) Summary # Applicant: MICRON CORPORATION 1-34-14 Higashiyukigaya Ohta-ku, Tokyo 145-0065 JAPAN Tel: 81 3 3726 0396 Fax: 81 3 3726 5396 Contact Person: Eiji Suzuki ## Date Summary Prepared: April 06, 1999 # Classification Name: Scaler Ultrasonic 21 CFR, 872.4850 # Common Name: Air scaler ## Trade Name: VIP 60 ## Predicate Devices: ## KAVO AMERICA'S SONICFLEX {1}------------------------------------------------ #### Intended Use The VIP 60 is an instrument of calculus and plaque removal which the dentist uses for dental treatment. This VIP 60 is used with scaling tips and a coolant water spray for debriding to heavy calculus and plaque deposits from tooth and root surfaces. ### Discription of Device #### Adavantages for patients 1.Much less pain as compared with ultrasonic scaling. - 2.Less oppressive pain and less irritation to the tooth and gingiva. - 3.Mush less bleeding - 4.Post operative refreshness from pocket irrigation. ### Adavantages for operators 1.Direct connection to handpiece hose is possible. - 2.Water spraying is minimum and working sites is clearly visible. - 3.As the scaler tip is much more delicate (thin), subgingival pockets, interdental areas and molar furcations could be reached. - 4.For the same reason, the feel of calculus adherence on the tooth can be transmitted to the operater's fingers, enabling careful and complete scaling even under indirect visualization. - 5.Similarly, because delicate manipulation is possible, operator can avoid direct touching of hypersensitive areas of the tooth. #### Note In using an ultrasonic scaler, it is indicated that the tip is favorably, kept at approximately 15 degrees during scaling in order to prevent injuring of the enamel. In the case of VIP60 (air scaler), the tip can approach the tooth surface in point contact which is more effective. ### Technological Characteristics and Substantial Equivalence The general componets, design, characteristics, and mode of operation of the VIP60 and accessories are substantially Equivalent to Kavo America's SONICFLEX. SONICflexLUX offers fiber optic illumination for maximum visibility in the scaling area. SONIX flexLUX permits the removal of calculcus and tartar by mechanical vibration. Coolant water actually runs through and exits at the tip -- where you need it. Designed for repeated sterilization. {2}------------------------------------------------ Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract human figures, possibly representing health, family, and community. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 1 8 1999 Mr. Eiji Suzuki Micron Corporation 1-34-14, Higashiyukigaya, Ohta-Ku Tokyo 145, Japan Re : K991239 VIP 60 (2H) Model 115-000-1 & VIP 60 (4H) Trade Name: Model 115-000-2 Regulatory Class: II Product Code: ELC July 20, 1999 Dated: Received: July 20, 1999 Dear Mr. Suzuki: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any {3}------------------------------------------------ Page 2 - Mr. Suzuki obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {4}------------------------------------------------ Page 1_of_1 #### 510(k) Number (if known): K991239 #### Device Name: VIP 60 Model 115-000-1 and Model 115-000-2 (Sonic Scaler) Indications For Use: The VIP 60 is an instrument of calculus and plaque removal which the dentist uses for dental treatment. This VIP 60 is used with scaling tips and a coolant water spray for debriding heavy calculus and plaque deposits from tooth and root surfaces. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) Susan Rinnols (Division Sign-Off) Division of Dental, Int and General Hoss 510(k) Number --- **Source:** [https://fda-staging.innolitics.com/device/K991239](https://fda-staging.innolitics.com/device/K991239) **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