The provided text focuses on demonstrating substantial equivalence to a predicate device rather than presenting explicit acceptance criteria with numerical targets. The "Significant Performance Characteristics" table highlights shared features between the applicant device and the predicate.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (EXTORAL / TESCERA GLAZING RESIN)
Intended Use	Must be a resin sealant.	Resin sealant.
Product Description	Must be a clear solution.	Clear solution.
Delivery System	Must be a brush.	Brush.
Biocompatibility	Must be non-toxic.	Ingredients were tested and found to be non-toxic.
Overall Safety and Efficacy	Must be safe and efficacious, demonstrating substantial equivalence to the predicate.	Concluded that information supplied proved safety and efficacy.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly mention a "test set" in the context of the device's performance. Instead, it refers to "side by side comparisons" and "biocompatibility testing."

Sample Size: Not specified for the comparison or biocompatibility testing. No explicit "test set" is described with a specific number of instances.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document states "ingredients... were tested," implying a laboratory setting, but provides no further details.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The study described focuses on direct comparison of product characteristics and biocompatibility testing, not on expert-adjudicated "ground truth" labels.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of a "test set" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document focuses on comparing the applicant device's intrinsic properties and intended use to a predicate device, not on how human readers' performance with or without AI assistance is affected.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a physical product (glazing resin), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" in this context is based on:

Direct comparison of product characteristics: Intended use, product description, and delivery system are directly observed and compared.
Biocompatibility testing results: Laboratory findings on the toxicity of the ingredients.
Predicate device characteristics: The legally marketed predicate device (Jet Seal/Ortho-Jet Acrylic Resin K941925) serves as the benchmark for "substantial equivalence."

8. Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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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 / TESCERAGLAZING RESIN	JET SEAL (ORTHO-JET ACRYLIC RESIN)
Intended Use	Resin sealant.	Resin sealant.
ProductDescription	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

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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.

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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

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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 -

Regulation Number and Section

§ 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.