(140 days)
Super adhesive system for adhering A-silicone and C-silicone impression materials on disposable plastic or light cured custom trays.
It is the intention of S & C Polymer GmbH to manufacture the TRAY-LINK cited above which can be used as adhesive system for adhering silicone impression materials on disposable plastic or light cured custom trays.
The cited TRAY-LINK material S & C Polymer GmbH manufactures for Pharmex and Henry Schein contains a chemistry commonly found in current dental materials.
The purpose of this material for use by the dentist or technician is to build a chemical link between impression materials and the impression trays.
The chemical compositions of the key components A-LINK of the TRAY-LINK system are substantially equivalent to the denture priming component A-Soft Prime of the product A-Soft Reline 510(k) K984483.
This document seems to be a 510(k) premarket notification for a dental adhesive product called TRAY-LINK. It describes the product's purpose, chemical composition, and regulatory information, but it does not contain any information about acceptance criteria, study designs, or performance data for a device in the context of the requested questions.
The provided text focuses on the regulatory submission process and the substantial equivalence to a predicate device (A-Soft Reline K984483). It explicitly states: "The chemical compositions of the key components A-LINK of the TRAY-LINK system are substantially equivalent to the denture priming component A-Soft Prime of the product A-Soft Reline 510(k) K984483." This indicates that the regulatory approval in this case relies on chemical substantial equivalence, not on a new performance study that would generate the kind of data you're asking for.
Therefore, I cannot provide the requested information based on the input text. The questions about acceptance criteria, study design, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth are not addressed in this 510(k) submission.
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S & C Polymer
TRAY-LINK - Premarket Notification 510(k) Submission - page 7
Image /page/0/Picture/3 description: The image shows the date November 2, 1999. The month is abbreviated as NOV. The day is the number 2, and the year is 1999. The text is in a simple, sans-serif font.
Image /page/0/Picture/4 description: The image shows a sequence of handwritten characters, specifically the alphanumeric string "K992001". The characters are written in a bold, dark font, which makes them stand out against the white background. The characters are large and take up most of the image. The string appears to be a code or identifier.
10. 510(k) Summary or Statement
SUMMARY
Gentleman:
This submission is pursuent to paragraph 510(k) of the Federal Drug and Cosmetic Act of May, 1976 (as amended) (Title 21 USC). All informations contained herein are to be considered and treated as CONFIDENTIAL COMMERCIAL INFORMATION.
It is the intention of S & C Polymer GmbH to manufacture the TRAY-LINK cited above which can be used as adhesive system for adhering silicone impression materials on disposable plastic or light cured custom trays.
S & C Polymer spezializes in manufacturing, distributing and marketing numerous dental materials and related items worldwide.
It is S & C Polymer GmbH's intention to manufacture the cited product herein at its facility located at Robert-Bosch-Straße 5. D-25335 Elmshorn (formerly Offenauer Weg 19. D-25335 Bokholt-Hanredder), Germany, employing Good Manufacturing Practices (GMP's) pursuant and according to Title 21 CFR. S & C Polymer GmbH is certified to DIN EN ISO 9001 / DIN EN 46001 and Medical Device Directive 93/42/EEC, annex II.
The above cited product may be offered and marketed in the United States by Pharmex and Henry Schein, in which case S & C Polymer will maintain control and govern the production and primary packaging. Pharmex and Henry Schein will maintain the claims, labels. instructions and indications by themselves which are consistent with this submission and final FDA 510(k) clearance to market by Pharmex and Henry Schein.
The cited TRAY-LINK material S & C Polymer GmbH manufactures for Pharmex and Henry Schein contains a chemistry commonly found in current dental materials.
The purpose of this material for use by the dentist or technician is to build a chemical link between impression materials and the impression trays.
The chemical compositions of the key components A-LINK of the TRAY-LINK system are substantially equivalent to the denture priming component A-Soft Prime of the product A-Soft Reline 510(k) K984483.
Respectfully submitted
Jürgen Engelbrecht, Ph. D.
Regulatory Compliance Officer
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The logo is printed in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 1999
Jurgen Engelbrecht, Ph.D. President S&C Polymer Robert-Bosch-Str. 5 D - 25335 Elmshorn Germany
Re : K992001 Trade Name: Tray-Link Requlatory Class: II Product Code: ELW Dated: June 10, 1999 Received: June 15, 1999
Dear Dr. Engelbrecht:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
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Page 2 - Dr. Engelbrecht
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 findinq 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 requlation 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
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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S & C Polymer
TRAY-LINK - Premarket Notification 510(k) Submission - page 6
9. Statement of Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
TRAY-LINK
Super adhesive system for adhering A-silicone and C-silicone impression materials on disposable plastic or light cured custom trays.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 5 i O(k) Number _
Prescription Use: __
Over-The-Counter Use:
§ 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).