The Ascent Pit & Fissure Sealant System is applied after the intended surface is prepared, etched, and treated as necessary. The material is applied to the site directly from the material packaging, usually in the form of a syringe or other hand-held dispensing apparatus. The sealant is worked into and around the affected area with a tip or brush to ensure an adequate and thorough coat. The material is then polymerized using a suitable dental polymerization light source. This system is marketed and sold only to licensed professional dentists.

Indications For Use:
Ascent Pit & Fissure Sealant is indicated for:

The sealing of pits and fissures

Device Description

The Ascent Pit & Fissure Sealant System is a comprehensive light-cured system designed to fill and seal the pits and fissures of teeth. The integrated nano-filler technology provides excellent wear and strength properties. The methacrylate based resin system provides an excellent seal and superior adhesion to etched enamel. The system may alternately be supplied either with or without a pretreatment phosphoric acid etchant.

AI/ML Overview

This 510(k) summary does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) that would typically be associated with a medical device AI/ML study. This document describes a traditional dental device (pit and fissure sealant), not a software-driven or AI-powered one.

Therefore, many of the requested fields cannot be filled as they are explicitly related to studies evaluating the performance of an AI/ML algorithm. The document explicitly states "Performance Standards: None" and "Performance Data: See Part 7: Performance Data," but "Part 7" is not included in the provided text.

Based on the available text:

Acceptance Criteria and Device Performance

Since this is a conventional dental sealant and not a software/AI device, acceptance criteria would typically relate to material properties (e.g., bond strength, wear resistance, viscosity, curing time) and biocompatibility, rather than diagnostic accuracy metrics. The provided document does not specify quantitative acceptance criteria. Instead, it relies on substantial equivalence to a predicate device.

Acceptance Criteria (Generic for Pit & Fissure Sealant)	Reported Device Performance (Not explicitly stated in this document)
Not specified in the provided text	Not explicitly stated in the provided text
(Would typically include properties like bond strength, wear resistance, biocompatibility, setting time, etc.)	(Would be evaluated against the predicate device's performance or standard material properties)

Study Details (Based on the provided text, many fields are not applicable or not available)

Sample size used for the test set and the data provenance: Not applicable. This is a material-based device, not an AI/ML algorithm tested on a dataset of images/data. The document does not describe a "test set" in the context of evaluating algorithm performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sealant device would be established through laboratory testing (e.g., mechanical tests, chemical analysis) or clinical trials, not expert consensus on annotated data.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: For a dental sealant, ground truth typically involves:
- In-vitro testing: Laboratory measurements of material properties (e.g., tensile strength, compressive strength, modulus of elasticity, wear resistance, bond strength to enamel/dentin, polymerization shrinkage, water sorption, solubility).
- Biocompatibility testing: As per ISO standards for medical devices.
- Clinical observation (if clinical trials were performed, though often not required for 510(k) for devices substantially equivalent to well-understood predicates): Assessment of retention rates, caries prevention, post-operative sensitivity.
  The document states "Performance Data: See Part 7," which is not provided.
The sample size for the training set: Not applicable. There is no "training set" in the context of machine learning for this device.
How the ground truth for the training set was established: Not applicable.

Summary based on available information:

The provided document, K053089 for Ascent Pit & Fissure Sealant, describes a traditional dental material. Its substantial equivalence is based on similar composition, indications for use, and application methods to a predicate device (Seal-Rite Pit and Fissure Sealant, K963921). The document explicitly states "Performance Standards: None" and references "Part 7: Performance Data" which is not included. Therefore, detailed acceptance criteria, study methodologies, and performance metrics (especially those relevant to AI/ML devices) are not present in this excerpt.

Summary

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IJEC 2 0 2005

K053089

510(k) Summary of Safety and Effectiveness

CAO GROUP 8683 S. 700 W. Sandy, UT 84070 Tel: 801.256.9282 Fax: 801.256.9287 www.caogroup.com Robert K. Larsen, Regulatory Affairs Manager Preparation Date: October 31, 2005

Device Name:

Trade Name:	Ascent Pit & Fissure Sealant
Common Name:	Pit and Fissure Sealant
Product Classification:	Pit and Fissure Sealant and Conditioner (21 CFR 872.3765,Product Code: EBC)

Legally Marketed Predicate Devices for Substantial Equivalence:

Seal-Rite Pit and Fissure Sealant, Manufactured by Pulpdent Corp. . 510(k) Number: K963921

Rationale for Substantial Equivalence:

The aforementioned device shares similarities for use in the oral cavity for the purpose of sealing pits and fissures in teeth. This device features similar composition, indications for use, and application methods.

Description of Submitted Device:

Intended Uses of the Ascent Pit & Fissure Sealant System:

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dispensing apparatus. The sealant is worked into and around the affected area with a tip or brush to ensure an adequate and thorough coat. The material is then polymerized using a suitable dental polymerization light source. This system is marketed and sold only to licensed professional dentists.

Technological Characteristics of Substantial Equivalence:

Both the submitted and predicate device are composed of similar substances: methacrylate resins, glass particle fillers, and photoinitiators. Both are slightly viscous liquids. Both have similar methods of application. Both are polymerized by dental curing lights.

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Performance Standards:

None

Performance Data

See Part 7: Performance Data

Conclusion

The Ascent Pit & Fissure Sealant System is substantially equivalent to the aforementioned predicate device with regards to purpose of the device, composition, methods of application, and indications for use without raising any new issues regarding safety and/or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2005

Mr. Robert K. Larsen Regulatory Affairs Manager CAO Group, Incorporated 8683 South 700 West Sandy, Utah 84070

Re: K053089

Trade/Device Name: Ascent Pit & Fissure Sealant Regulation Number: 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: October 31, 2005 Received: November 2, 2005

Dear Mr. Larsen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rottomed your and have determined the device is substantially equivalent (for the relerenced above and have actesmanosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mersate ecomments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to arrives and Cosmetic Act (Act) that do not require approval of a premarket the Federal F Uou may, therefore, market the device, subject to the general approval applivation (the Act. The general controls provisions of the Act include controls provided by 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 If your device in elaberied (oos as additional controls. Existing major regulations afficting (1 Mrs), it may of subject to tass of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Larsen

Please be advised that FDA's issuance of a substantial equivalence determination does not r case oc advisod that 1 DT o lesaultes on that your device complies with other requirements moun mat 1 DA mas mass statutes and regulations administered by other Federal agencies. of the Act of ally I oderal bute and systements, including, but not limited to: registration 1 ou must comply with a 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 Of rear 807), and ity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (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) I mis letter will and in Jobb on finding of substantial equivalence of your device to a premaired 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), rr you desire specific at no reach 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 may obtain other generational 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/industry/support/index.html.

Sincerely yours,

Sytie y. M.hie. Omd
Chia Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Ascent Pit & Fissure Sealant

Indications For Use:

Ascent Pit & Fissure Sealant is indicated for:

· The sealing of pits and fissures
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)
OR Over-The-Counter Use

Susen Kurser

Norma Chemosa Ho

K05.3089

Regulation Number and Section

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.