(91 days)
- Sealing pits and fissures, damaged enamel surfaces and exposed dentin surfaces e of teeth to prevent caries
- Protective coating for tooth surfaces predisposed to caries or on early non- cavitated lesions (org. including use in tooth brush abrasion and root surfaces).
Covering of caries predilection sites during orthodontic treatment
SPK Sealant is moisture activated, light-cured, fluoride releasing pit and fissure sealant that can be applied with or without a phosphoric acid etch step. SPK Sealant is classified as a pit and fissure sealant because the device is composed of a methacrylate-based resin intended for sealing pits and fissures or other tooth surfaces to prevent cavities.
The provided 510(k) summary for K091632, "SPK Sealant," does not contain a detailed study section with acceptance criteria and a comprehensive study showing device performance. This type of information is usually found in a separate biocompatibility report, performance testing report, or clinical study report, which is referenced or summarized within a more detailed 510(k) submission but often not fully included in the public 510(k) summary document itself.
The document states: "Based on the indications for use, technological characteristics, and comparison of the predicate devices, the SPK Sealant has been shown to be safe and effective for its intended use." This is a general statement of equivalence rather than a detailed report of a specific study to meet acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
To answer your request, a more detailed study report or performance testing summary would be required.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
- Not explicitly provided in the given text. The document focuses on demonstrating substantial equivalence to predicate devices, implying that its performance is comparable, but it does not present specific acceptance criteria (e.g., bond strength, fluoride release, retention rate) and then show how this new device met those criteria through a study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided.
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/Not provided. This type of information is typically related to diagnostic imaging or clinical interpretation studies, which is not the nature of this dental sealant submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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/Not provided. This is relevant to AI/diagnostic imaging devices, not a dental sealant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated/Not applicable. Performance for dental sealants is typically assessed through characteristics like bond strength, wear resistance, fluoride release, and clinical retention over time, rather than a "ground truth" as might be used in a diagnostic test.
8. The sample size for the training set:
- Not applicable/Not provided. This is relevant for machine learning algorithms, which this device is not.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
In summary, the provided 510(k) summary primarily focuses on demonstrating substantial equivalence to existing predicate devices based on indications for use and technological characteristics, rather than detailing a specific, comprehensive study with explicit acceptance criteria and performance data for this particular device.
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K091632
2110898
510(k) Summary
Image /page/0/Picture/2 description: The image shows the logos of two companies, 3M and ESPE. The 3M logo is on the left, and the ESPE logo is on the right. Both logos are in black and white and have a grainy texture. The logos are displayed side-by-side.
August 28, 2009
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
3M ESPE Dental Products 3M Center, Bldg. 275-2 W-08 St. Paul, MN 55144-1000 USA
SEP - 3 2009 1
Establishment Registration Number
Contact Person
- Device Name Common Name Classification Name Regulation Class Panel Product Code
Shari Myszka Regulatory Affairs Specialist Phone: (651) 736-6955 Fax: (651) 736-1599 simvska@mmm.com
SPK Sealant Dental Sealant, Pit and Fissure Sealant Pit and Fissure Sealant and Conditioner 21 CFR 872.3765 II. Dental EBC
Predicate Devices
| 510(k) | Device Name |
|---|---|
| K992326 | Clinpro Sealant, 3M ESPE Dental Products |
| K011491 | Heliodeal Clear Chroma, Ivoclar NA, Inc. |
| K062344 | Grandio Seal, VOCO GmbH |
| K061997 | Enamel Loc Sealant, Premier Dental Products Company |
| K073395 | Glass Ionomer Protective Coating, 3M ESPE Dental Products |
Description and Technology Equivalence:
SPK Sealant is moisture activated, light-cured, fluoride releasing pit and fissure sealant that can be applied with or without a phosphoric acid etch step. SPK Sealant is classified as a pit and fissure sealant because the device is composed of a methacrylate-based resin intended for sealing pits and fissures or other tooth surfaces to prevent cavities. Based on the indications for use, technological characteristics, and comparison of the predicate devices, the SPK Sealant has been shown to be safe and effective for its intended use.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol that resembles three abstract shapes, possibly representing human figures or abstract forms, arranged in a vertical stack.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002
Shari L. Myszka, R.Ph., Pharm.D. Regulatory Affairs Specialist 3M Company 3M ESPE Dental Products 3M Center, Building 275-2W-08 St. Paul, Minnesota 55144-1000
SEP - 3 2009
Re: K091632
Trade/Device Name: SPK Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: August 28, 2009 Received: September 1, 2009
Dear Dr. Myszka;
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 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 - Dr. Myszka
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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Wh fac
Susan Runner, D.D.S., M.A. Acting Division 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
510(k) Number (if known): K091632
Device Name: SPK Sealant
Indications for Use:
- Sealing pits and fissures, damaged enamel surfaces and exposed dentin surfaces e of teeth to prevent caries
- Protective coating for tooth surfaces predisposed to caries or on early non-� cavitated lesions (org. including use in tooth brush abrasion and root surfaces).
Covering of caries predilection sites during orthodontic treatment �
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Kei. Muluy for MSP
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091632
§ 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.