(94 days)
The Acquaseal Benz is indicated for dental restorative, hypersensitivity, cervical, and hygiene procedures.
Hydrophilic liquid containing Hydroxyethyl- methacrylate (HEMA), Fluoride and Benzakonium Fluoride.
The provided document is a 510(k) Pre-Market Notification for a dental bonding agent called "Acquaseal Benz". It aims to establish substantial equivalence to a predicate device, "Hema-Benz" (K953405).
This document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in the context of typical AI/software device evaluation.
Instead, it focuses on demonstrating that the new device ("Acquaseal Benz") is substantially equivalent to an existing, legally marketed device ("Hema-Benz") based on its intended use, technological characteristics, and descriptive information (ingredients, purpose, properties). This is a regulatory pathway that often does not require new clinical studies if substantial equivalence can be shown through comparison with a predicate device.
Therefore, for almost all the requested information, the answer will be that the document does not provide it, as those types of studies and criteria are typically associated with novel devices or devices where substantial equivalence cannot be established through comparison alone.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report specific device performance metrics (e.g., bond strength, desensitization efficacy rates, durability scores) from a dedicated study. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device, meaning the new device is expected to perform at a comparable level to the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable - This document establishes substantial equivalence, which implies comparable performance to the predicate device without specifying quantitative criteria for the new device's independent performance. | Not applicable - No specific performance metrics for Acquaseal Benz are reported from an independent study in this document. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The document is a 510(k) pre-market notification based on comparison to a predicate device, not a report of a new clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The document does not describe a study involving a test set that required expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication method described.
5. 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/software device, and no MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no new study requiring independent ground truth establishment described in this document. The "ground truth" for regulatory purposes here is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/software device and no training set is mentioned.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/software device and no training set is mentioned.
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|<070289
MAY - 4 2007
SUMMARY & STATEMENT OF COMPARISON (as per 21 CFR 807.92c)
| 1) Submitted by: | Hugh Palmer, Official CorrespondentAcquamed Technologies, Inc.33 West 480 Fabyan Parkway, Unit 105West Chicago, IL 60185 (Tel: 630-232-8704) | |
|---|---|---|
| 2) Establishment Registration No: | 3004691767 | |
| 3) Date Prepared: | 01/15/07 | |
| 4) Product Proprietary Name: | Acquaseal Benz | |
| 5) Device Common Name:Resin Tooth Bonding Agent | ||
| 6) Device Classification Name: | Agent, Tooth Bonding, Resin(21 CFR 872.3200) | |
| 7) Device Class: | Class II (KLE) | |
| 8) Substantial equivalence: | The Acquaseal Benz manufactured and marketed byAcquamed Technologies, Inc., is substantially equivalentto the Legally Marketed Predicate: Hema-Benz(K953405) originally manufactured by Health-Dent, Intl.(Refer to section VI of this submission.) |
The 510(k) Substantial Equivalence Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:
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- The Acquaseal Benz and the Hema Benz listed above have the same intended use, that being as varnish on sensitive teeth, over exposed dentin on exposed dentin on roots.
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- The technological characteristics for this product are the same as the predicate device listed as the ingredients are the same. No significant variation has been implemented.
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- Descriptive information per the table noted below further show that the materials from the listed predicate devices are substantially equivalent as they are used for the same purpose and have same properties.
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- As noted above, the Substantial Equivalence Decision-Making Process Chart was used.
See below for a comparison table showing similarities and differences from the predicate
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devices listed supporting substantial equivalence.
Similarities:
| AcquaSeal Benz | Legally Marketed Predicate: Hema-Benz(K953405) |
|---|---|
| Hydrophilic liquid containing Hydroxyethyl- methacrylate (HEMA), Fluoride and Benzakonium Fluoride. | Hydrophilic liquid containing Hydroxyethyl- methacrylate (HEMA), Fluoride and Benzakonium Fluoride. |
| Indicated as a bonding agent for dental restoration. | Indicated as a bonding agent for dental restoration. |
| Desensitizing; Mechanically occludes the dentinal tubules due to polymerization to decrease hypersensitivity. | Desensitizing; Mechanically occludes the dentinal tubules due to polymerization to decrease hypersensitivity. |
Differences:
| AcquaSeal Benz | Legally Marketed Predicate: Hema-Benz(K953405) |
|---|---|
| As the predicate, the Acquaseal Benz is indicateddental restorative procedures anddesensitization, but is also indicated for cervicaland hygiene procedures as the liquid is appliedwith a cotton swab tipped device. | As this product's predecessor, Hema-Glu(K951220) the Hema-Benz is indicated for dentalrestoration and desensitization. Both of theseproducts are noted for use with adhesive bondingsystems and crown and bridge luting agents toeliminate post treatment sensitivity. They are alsorecommended for the treatment of dentin orcementum sensitivity following root planning andperiodontal surgery and can be used prior toplacing amalgam restorations.The above referenced products were developed tobe applied with a cotton pellet. |
Conclusion:
Per the review noted above in accordance with the guidance document, the Acquaseal Benz is found to be substantially equivalent to the identified predicate device.
Date:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Acquamed Technologies, Incorporated C/O Ms. Tammy Lavery Regulatory Affairs, Senior Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
MAY - 4 2007
Re: K070289
Trade/Device Name: Acquaseal Benz Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Codes: LBH and KLE Dated: April 25, 2007 Received: April 26, 2007
Dear Ms. Lavery:
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.
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Page 2 – Ms. Tammy Lavery
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tease be advised that I Drive issualized to your device complies with other requirements of the Act or that FDA has made a doctoring administered by other Federal agencies. You must comply with ally Federal statutes and regulations as limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements; incrading, vefactice requirements as set forth in the quality labeling (21 CFR Part 801); good manager, 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) I ms letter will anow you'to begin mailioning of substantial equivalence of your device to a legally prematics notification: "The PDF macilassification 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), please If you desire specific acrive ion 1041) 276-0115. Also, please note the regulation entitled, Colliact the Office of Complanes as (27/2 notification" (21 CFR 807.97). You may obtain other Misorancing of Forerence to promoibilities under the Act from the Division of Small general information on your responsibility of the enumber (800) 638-2041 or Manufacturers, micrnational and Ocess http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Kune
Chin S. Lin, PhD
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
107078 510(k) Number (if known):
Device Name: Acquaseal Benz
Indications for Use:
The Acquaseal Benz is indicated for dental restorative, hypersensitivity, cervical, and hygiene procedures.
Prescription Use X AND/OR
(Per 21 801 CFR Subpart D)
Over-The-Counter Use
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russer
Page 1 of 1 (Posted November 13, 2003)
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- 1 The of Anesthestology, General Hospital, John Control, Dental Devices 1 1 0(k) Number ____
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§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.