(41 days)
No
The description focuses on material properties (nano-filler, methacrylate resin, fluoride releasing compound) and the intended use as a sealant. There is no mention of AI, ML, image processing, or data-driven analysis.
No
This device is a sealant used to fill and seal the pits and fissures of teeth, which is a preventative measure rather than a therapeutic treatment for an existing condition.
No
Explanation: The device is a sealant used to fill and seal the pits and fissures of teeth, which is a therapeutic rather than a diagnostic function. It is used for treatment, not for identifying a disease or condition.
No
The device description clearly states it is a "light-cured system" and mentions "integrated nano-filler technology" and "methacrylate based resin system," indicating it is a physical material and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "The sealing of pits and fissures." This is a direct treatment applied to the tooth structure.
- Device Description: The description details a material used to fill and seal tooth surfaces.
- Anatomical Site: The anatomical site is the "oral cavity (teeth, pits and fissures)." This is a part of the body being treated.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
This device is a dental material used for a restorative or preventative procedure directly on the tooth, not for testing a sample outside the body.
N/A
Intended Use / Indications for Use
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.
Ascent Pit & Fissure Sealant is indicated for:
- The sealing of pits and fissures
Product codes (comma separated list FDA assigned to the subject device)
EBC
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. The modification made to the device as originally submitted is the addition of a secondary material in the form of a fluoride releasing compound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity (teeth)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed professional dentists
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K06 2886
510(k) Summary of Safety and Effectiveness
CAO GROUP 4628 West Skyhawk Drive West Jordan, UT 84084 Tel: 801.256.9282 Fax: 801.256.9287 www.caogroup.com Robert K. Larsen, Operations Director Preparation Date: November 3, 2006
NUV -6 2006
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:
- Clinpro Sealant, Manufactured by 3M Company . 510(k) Number: K992326
- 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:
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. See also Part 6: Specifications
The modification made to the device as originally submitted is the addition of a secondary material in the form of a fluoride releasing compound.
1
Intended Uses of the Ascent Pit & Fissure Sealant System:
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.
Technological Characteristics of Substantial Equivalence:
Both the submitted and predicate devices are composed of similar substances: methacrylate resins, glass particle fillers, and photoinitiators. Additionally, the submitted device and the Clinpro Sealant predicate device contain fluoride releasing agents. Both the submitted and predicate devices are slightly viscous liquids. All have similar methods of application. All are polymerized by dental curing lights.
Performance Standards:
None
Performance Data
See Part 7: Performance Data
Conclusion
The Ascent Pit & Fissure Sealant System as submitted 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. The device as submitted is identical in Indications for Use, application, labeling - except the addition of reference to the fluoride release compound, and methods of manufacture as compared to the original device submitted and approved under 510(k) Number K053089. The device as submitted is identical in composition in all respects except for the addition of a fluoride releasing compound which serves as a secondary chemical constituent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is facing left. The text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert K. Larsen Operations Director CAO Group Incorporated 4628 West Skyhawk Drive West Jordan, Utah 84084
Re: K062886
Trade/Device Name: Ascent Pit and Fissure Scalant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: September 13, 2006 Received: October 11, 2006
Dear Mr. Larsen:
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.
NOV - 6 2006
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.
3
Page 2 - Mr. Robert K. Larsen
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); 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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/cdrb/industry/support/index.html
Sincerely yours,
Cluets
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
4
Indications for Use
510(k) Number (if known):
Ko62886
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)
Susan Knopke
esinesiology, General Hosp. J. rol, Dental Devic
Kowasek
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use OR