PLASTALGIN AND PLASTALGIN ORTHO

K032708 · Septodont · ELW · Nov 20, 2003 · Dental

Device Facts

• Record ID: K032708
• Device Name: PLASTALGIN AND PLASTALGIN ORTHO
• Applicant: Septodont
• Product Code: ELW · Dental
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Use Plastalgin for all routine impressions (e.g., denture dentition construction, orthodontics, study models, or other such routine impressions). Use Plastalgin Ortho when a faster setting time is needed (e.g., procedure with children, patients with nauseous reflex during impression procedures).

Device Story

Plastalgin and Plastalgin Ortho are dental impression materials used by dental professionals to create physical molds of oral structures. The materials are mixed and applied to the patient's mouth to capture anatomical details for prosthodontics, orthodontics, or diagnostic study models. Plastalgin Ortho is formulated with a faster setting time to improve patient comfort, specifically for pediatric patients or those prone to gagging. The device functions as a traditional dental impression material; it does not involve digital inputs, software, or automated processing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental impression material; physical/chemical setting mechanism. No software, electronics, or energy source. Formulated for standard (Plastalgin) or rapid (Plastalgin Ortho) setting times.

Indications for Use

Indicated for dental patients requiring routine impressions for denture construction, orthodontics, or study models. Plastalgin Ortho is indicated for patients requiring faster setting times, including children and patients with a sensitive gag reflex.

Regulatory Classification

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).

Submission Summary (Full Text)

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Public Health Service

NOV 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEPTODONT C/O Mr. Wayne H. Matelski, Esq. Counsel for Septodont Arent Fox Kintner Plotkin & Kahn, PLLC 1050 Connecticut Avenue, NW Washington, District of Columbia 20036-5339

Re: K032708

Trade/Device Name: Plastalgin and Plastalgin Ortho Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: November 13, 2003 Received: November 14, 2003

Dear Mr. Matelski:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Wayne H. Matelski, Esq.

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Signature

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K032708

Device Name: Plastalgin and Plastalgin Ortho

Indications For Use:

Use Plastalgin for all routine impressions (e.g., denture dentition construction, orthodontics, study models, or other such routine impressions).

Use Plastalgin Ortho when a faster setting time is needed (e.g., procedure with children, patients with nauseous reflex during impression procedures).

Prescription Use _ ___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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)

Suse Burns

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

KOBOZOR 510(k) Number: _