(91 days)
Not Found
No
The document describes a traditional dental sealant and does not mention any AI or ML components or functionalities.
No
The device is described as a sealant for preventing caries/cavities, which is a prophylactic measure rather than a treatment for an existing condition.
No
The device is described as a sealant for preventing caries and is classified as a pit and fissure sealant. It is a protective coating, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a "moisture activated, light-cured, fluoride releasing pit and fissure sealant composed of a methacrylate-based resin," indicating it is a physical material applied to teeth, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device applied directly to the surface of teeth to prevent caries. This is a therapeutic or preventative application within the body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The description confirms it's a sealant applied to tooth surfaces.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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
Product codes
EBC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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)
K992326, K011491, K062344, K061997, K073395
Reference Device(s)
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
§ 872.3765 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.
0
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.
1
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.
2
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
3
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