(74 days)
Not Found
Not Found
No
The summary describes a dental etching gel, a chemical product, with no mention of software, image processing, or AI/ML terms.
No
The device is described as being "For etching dentin and enamel," which is a preparative action rather than a treatment for a disease or condition. Therapeutic devices are typically used to treat, cure, mitigate, or prevent disease.
No
Explanation: The device is described for "etching dentin and enamel," which is a preparative or treatment function, not a diagnostic one. It's used by a "dentist," implying a treatment and not a diagnostic role based on the given information. The "Predicate Device(s)" also refers to "ETCH GEL," further supporting its role as a treatment material rather than a diagnostic tool.
No
The 510(k) summary describes a device for "etching dentin and enamel," which is a physical process typically performed by a chemical agent (like an etch gel, as indicated by the predicate device). There is no mention of software, image processing, AI, or any other characteristic that would suggest a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For etching dentin and enamel." This is a procedure performed directly on a patient's teeth, not on a sample of bodily fluid or tissue in vitro (outside the body) for diagnostic purposes.
- Anatomical Site: The anatomical site is "dentin and enamel," which are parts of the tooth within the patient's mouth.
- Lack of Diagnostic Information: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens (like blood, urine, or tissue) to provide information for diagnosing, monitoring, or treating diseases or conditions. This device's function is a direct dental procedure.
N/A
Intended Use / Indications for Use
For etching dentin and enamel.
Product codes
EBF
Device Description
It is the intention of S & C Polymer GmbH to manufacture the ETCHING GEL cited above which can be used as an etching material for dental use.
The purpose of this material for use by the dentist is to clinically reline dentures. The material is in general placed against an applied adhesive system on the protheses.
The cited ETCHING GEL S & C Polymer GmbH manufactures for Pharmex and Henry Schein contains Pharmex and Henry Schein and chemistry commonly found in current dental materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin and enamel (dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
S & C Polymer
JUL - 9 1999
10. 510(k) Summary or Statement
K99450
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 ETCHING GEL cited above which can be used as an etching material for dental use.
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 ETCHING GEL S & C Polymer GmbH manufactures for Pharmex and Henry Schein contains Pharmex and Henry Schein and chemistry commonly found in current dental materials.
The purpose of this material for use by the dentist is to clinically reline dentures. The material is in general placed against an applied adhesive system on the protheses.
The chemical composition and use of ETCHING GEL is substantially equivalent to "ETCH GEL", a product manufactured and marketed as an own brand by HENRY SCHEIN. S & C Polymer GmbH's and HENRY SCHEIN's intended use, performance, indications, proposed labels and instructions for use (see attached) are substantially similar to the predicted device (see attached).
Respectfully submitted
Jürgen Engelbrecht, Ph. D.
Regulatory Compliance Officer
1
Image /page/1/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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with lines suggesting movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 1999
Jurgen Engelbrecht, Ph.D. President Regulatory Compliance Officer Silicon-und Composite Spezialitaten GmbH Robert-Bosch-Strasse 5 Elmshorn GERMANY
Re : K991450 ETCHING GEL Trade Name: Regulatory Class: II Product Code: EBF Dated: April 1, 1999 Received: April 26, 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Engelbrecht
this response to your premarket notification Please note: submission does not affect any 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
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): | K991450 | Page 1 of 1 |
|---|---|---|
| Device Name: | ETCHING GEL | |
| Indications For Use: | For etching dentin and enamel. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PA NEEDED)
Concurrence of CDRH, Office of Device Evaluation (QDE)
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Forma |
|---|---|---|
| --------------------------------------- | ---- | -------------------------------------- |
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number
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