(44 days)
Hydrogum is an alginate dental impression material that is intended to be used to make dental impressions. The resulting impressions are used to make plaster models of the teeth.
Hydrogum is an alginate dental impression material.
I'm sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) clearance letter for a dental impression material (Hydrogum) and an "Indications for Use Statement." These documents do not contain information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth methodologies as would be found in a clinical study report or a more detailed regulatory submission.
The letter primarily focuses on:
- Confirming the substantial equivalence of Hydrogum to a legally marketed predicate device.
- Outlining regulatory requirements for the manufacturer.
- Stating the intended use of the device.
Therefore, the specific quantitative details you're asking for regarding device performance and study methodology are not present in this text.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 2005
Zhermack S.P.A. C/O Mr. Gerald Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702
Re: K974704 Trade/Device Name: Hydrogum Regulatory Class: II Product Code: ELW Dated: December 16, 1997 Received: December 16, 1997
Dear Mr. Shipps:
This letter corrects our substantially equivalent letter of January 29, 1998 regarding the Indications for Use form.
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 (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 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. Shipps
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 continue 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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Clue
Chiu Lin, Ph.D. 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 STATEMENT
510(k) Number:
Device Name:
Hydrogum
Indications For Use:
Hydrogum is an alginate dental impression material that is intended to be used to make dental impressions.
The resulting impressions are used to make plaster models of the teeth.
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Concurrence of CDRH, Office of Device Evaluation (ODE) 20000 (Division Sign-Off) Division of Dental, Infection Control, and General Hospit 12 VC 510(k) Number Prescription Use, OR Over-The-Counter Use (per 21 CFR 801.109) (Optional Formst 1-2-96)
§ 872.3660 Impression material.
(a)
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.(b)
Classification. Class II (Special Controls).