(48 days)
No
The summary describes a dental sealant with nano-filler technology and resin, but makes no mention of AI or ML.
No
This device is a sealant used to fill and seal pits and fissures in teeth, preventing decay rather than treating an existing disease or condition. It is a preventative and restorative material.
No
Explanation: The device is a pit and fissure sealant, which is a dental material used to prevent cavities by filling and sealing pits and fissures in teeth. This is a treatment/preventative device, not a diagnostic one.
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, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a light-cured resin system designed to fill and seal tooth surfaces. This is a material used for a restorative or preventative dental procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device is clearly a dental material used for a clinical procedure within the oral cavity.
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.
Indications For Use:
Ascent Pit & Fissure Sealant is indicated for:
- The sealing of pits and fissures
Product codes
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.
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
See Part 7: Performance Data
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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:
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
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
1
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.
の 2007年の1000年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年には1000年に1000
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.
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 stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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.
3
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
4
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