VITAPEX PRE-LOADED DENTAL SYRINGE

K973667 · Neodental Chemical Products Co., Ltd. · KIF · Nov 6, 1997 · Dental

Device Facts

• Record ID: K973667
• Device Name: VITAPEX PRE-LOADED DENTAL SYRINGE
• Applicant: Neodental Chemical Products Co., Ltd.
• Product Code: KIF · Dental
• Decision Date: Nov 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for apexegenesis or apexification, and / or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.

Device Story

Vitapex is a pre-loaded dental syringe containing a paste of calcium hydroxide and iodoform. Used by dentists during endodontic procedures; applied directly into prepared root canals. The paste acts as a medicament to prevent bacterial contamination and stimulate hard tissue induction/deposition. It serves as a permanent, low-volume additive during the final filling process with gutta-percha. Benefits include accelerated and more complete healing of the root canal system.

Clinical Evidence

No clinical data provided; device cleared based on substantial equivalence to existing dental medicaments.

Technological Characteristics

Pre-loaded dental syringe delivery system. Contains calcium hydroxide and iodoform paste. Chemical-based therapeutic agent for endodontic use.

Indications for Use

Indicated for patients requiring root canal therapy, including treatment of infected root canals, post-pulpectomy, apexogenesis, or apexification. Used as a medicament and as an additive during final gutta-percha filling to promote hard tissue deposition and prevent bacterial contamination.

Regulatory Classification

Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Kyle H. Sibinovic, Ph.D. Neo Dental Chemical Products Company, Ltd. C/O Shaldra, Incorporated 7613 Carteret Road Bethesda, Maryland 20817

NOV - 6 1997

Re : K973667 Vitapex Pre-Loaded Dental Syringe Trade Name: Requlatory Class: II Product Code: KIF Dated: September 25, 1997 Received: September 25, 1997

Dear Dr. Sibinovic:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timo Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

.Enclosure

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## 510 (k) Number (if known): 长9736007

## Device Name: NeoDental Vitapex Paste

Indications for Use: For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for apexegenesis or apexification, and / or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
|-----------------------------------------------------------------------------------------------|----------|--------------------------------------------------|--|
| Susan Kunnes | | | |
| (Division Sign-Off)<br>Division of Dental, Infection Control,<br>and General Hospital Devices | | | |
| 510(k) Number | KC973667 | | |
| Prescription Use<br>(Per 21 CFR801 109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) | |