(51 days)
Not Found
No
The summary describes a surface sealant for indirect composites and does not mention any AI or ML capabilities.
No
The device is a surface sealant for indirect composites, which is a dental material and not a device intended for therapeutic purposes like treating or preventing a disease.
No
This device is described as a "surface sealant" and "glaze" for indirect composites and resin composite restorations. Its intended use is to seal surfaces, not to diagnose conditions.
No
The device description clearly states it is a "single bottle glaze for use on indirect resin composite restorations," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a surface sealant for indirect composites." This describes a material applied to a dental restoration, not a test performed on a biological sample to diagnose a condition.
- Device Description: The description is of a "single bottle glaze for use on indirect resin composite restorations." This further reinforces its nature as a dental material.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The information provided clearly indicates this is a dental material used in the restoration process, not a diagnostic test.
N/A
Intended Use / Indications for Use
This product is used as a surface sealant for indirect composites.
Product codes (comma separated list FDA assigned to the subject device)
EBD
Device Description
A single bottle glaze for use on indirect resin composite restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be a word or a name. The text is written in a cursive style with some letters connected. The writing is somewhat messy and difficult to read, but it seems to contain a combination of uppercase and lowercase letters. The text is written in black ink on a white background.
Section 5-1
Contact: David Vozick
SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 190 and 21 CFR par 807.92
EXTORAL/TESCERA GLAZING RESIN Trade Name: GLAZE Common Name: Denture, Relining, Repairing, or Rebasing Resin Classification name: Class II per 21 CFR 872.3760
Description of Applicant Device:
A single bottle glaze for use on indirect resin composite restorations.
Intended uses of Applicant Device:
Intended to be used primarily as a glaze on resin composites.
Predicate Devices: Jet Seal / Ortho-Jet Acrylic Resin K941925 (clearance date of 05/27/94)
Significant Performance Characteristics:
| | EXTORAL / TESCERA
GLAZING RESIN | JET SEAL (ORTHO-
JET ACRYLIC RESIN) |
|------------------------|------------------------------------|----------------------------------------|
| Intended Use | Resin sealant. | Resin sealant. |
| Product
Description | Clear solution. | Clear solution. |
| Delivery System | Brush | Brush |
Side by side comparisons of EXTORAL/TESCERA GLAZING RESIN to the predicate device Jet Seal (Ortho-Jet) clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. The ingredients of EXTORAL/TESCERA GLAZING RESIN were tested for biocompatibility and were found to be non-toxic.
It is concluded that the information supplied in this submission has proven the safety and efficacy of EXTORAL/TESCERA GLAZING RESIN.
CONFIDENTIAL, December 14, 2001
David Vozick Chairman AFP Imaging Corporation 1 914 592 6100
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 7 2002
Mr. David Vozick Chairman AFP Imaging Corporation 250 Clearbrook Road Elmsford, New York 10523
Re: K014144
Trade/Device Name: Extoral/Tescera Glazing Resin Regulation Number: 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: December 14, 2001 Received: December 18, 2001
Dear Mr. Vozick:
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.
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.
2
Page 2 - Mr. David Vozick,
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of Sect. 2
510(k) Number (if known): K014144
Device Name: EXTORAL/TESCERA GLAZING RESIN
Indications For Use:
This product is used as a surface sealant for indirect composites.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-08)
Susan Dunn
(Division Sign-Off) Division Sign Collins of Dentrol, and General Hospital F 10(k) Number -