(80 days)
Not Found
No
The device description and intended use describe a chemical primer, and there is no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device is a primer used to condition dental appliances, which is a preparatory step for adhesion and does not directly treat or prevent a disease or condition.
No
Explanation: The device is a primer used for conditioning porcelain dental appliances, not for diagnosing medical conditions.
No
The device description clearly states it is a "clear, low viscosity liquid composition" marketed in "preloaded 3cc syringes," indicating it is a physical substance 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 for conditioning porcelain dental appliances prior to placement or adhesion within the oral cavity. This is a direct application to a material that will be used in the body, not for testing a sample taken from the body to diagnose a condition.
- Device Description: The description details a liquid composition for surface conditioning, not a reagent or kit for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing a disease or condition, or providing information about a patient's health status based on in vitro testing.
The device is a dental material used for preparing a surface for bonding, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Ascent Prep Porcelain Primer is indicated for the conditioning of porcelain dental appliances prior to the placement or adhesion of said porcelain to tooth structures within the oral cavity, resin based tooth restorative materials, or to other porcelain oral appliances.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
The Ascent Prep Porcelain Primer is a clear, low viscosity liquid composition containing conditioners and demineralizers in a solvent carrier. The liquid is marketed in preloaded 3cc syringes, which are shrink-wrapped for safety and marked with batch information for manufacturing traceability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity / tooth structures
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): 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.
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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
K091/300
510(k) Summary of Safety and Effectiveness
CAO GROUP 4628 West Skyhawk Drive Sandy, UT 84070 Tel: 801.256.9282 Fax: 801.256.9287 www.caogroup.com Robert K. Larsen, Regulatory Director Preparation Date: April 6, 2009
JUL 2 8 2009
Device Name:
| Trade Name: | Ascent Prep Porcelain Primer |
|---|---|
| Common Name: | Porcelain conditioner |
| Product Classification: | Agent, Tooth Bonding, Resin (21 CFR 872.3200, Product |
| Code: KLE) |
Legally Marketed Predicate Devices for Substantial Equivalence:
- Porcelain Primer, Manufactured by J. Morita USA, Inc. ● 510(k) Number: K061322
- Clearfil Ceramic Primer, Manufactured by Kuraray Medical, Inc. . 510(k) Number: K061906
- Ultradent Porcelain Etch, Manufactured by Ultradent Products, Inc. . 510(k) Number: K951582
Rationale for Substantial Equivalence:
The aforementioned device shares similarities for use with the predicate devices on appliances intended for placement in the oral environment by means of conditioning the surface of porcelain dental appliances preparatory to the adhesion to or placement of said porcelain to teeth, resin based tooth restorative materials, or other oral appliances. This device features similar indications for use and application methods to the predicate devices.
Description of Submitted Device:
The Ascent Prep Porcelain Primer is a clear, low viscosity liquid composition containing conditioners and demineralizers in a solvent carrier. The liquid is marketed in preloaded 3cc syringes, which are shrink-wrapped for safety and marked with batch information for manufacturing traceability. Exact information regarding the material's constituents is found in Part 6: Specifications
1
Intended Uses of the Ascent Custom Fluoride Tray System:
Ascent Prep Porcelain Primer is intended for application on any porcelain appliance meant for placement in the oral cavity. The device is applied directly to the porcelain material by means of a disposable applicator tip attached to the delivery svringe. The device composition is dispensed on the surface of the porcelain and spread to cover the desired surface with an ample coating of the composition. After the proscribed time, the carrier liquid is evaporated with a gentle air stream. The composition works to create an adhesion interface between the porcelain substance and resin-based adhesive materials commonly utilized in dentistry.
Technological Characteristics of Substantial Equivalence:
Both the submitted and predicate devices are composed of similar substances, with similar active constituents in similar concentrations. Both have similar indications for use. Both have similar methods of application. Both are used in conjunction with dental restorative and preventative procedures. See Part 7: Performance Data.
Performance Standards:
ISO 7405:1997. Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials
Performance Data
See Part 7: Performance Data
Conclusion
The Ascent Prep Porcelain Primer is substantially equivalent to the aforementioned predicate device with regards to purpose of the device, general 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 & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The text is in all caps and is relatively small compared to the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert K. Larsen Regulatory Director CAO Group, Incorporated 4628 West Skyhawk Drive West Jorden, Utah 84084
JUL 2-8 2009
Re: K091300
Trade/Device Name: Ascent Prep Porcelain Primer Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code; KLE Dated: April 6, 2009 Received: May 6, 2009
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.
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.
3
Page 2 - Mr. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
for
Susan Runner, D.D.S., M.A. Acting 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):
Ko 91300
Device Name: Ascent Prep Porcelain Primer
Indications For Use:
Ascent Prep Porcelain Primer is indicated for the conditioning of porcelain dental appliances prior to the placement or adhesion of said porcelain to tooth structures within the oral cavity, resin based tooth restorative materials, or to other porcelain oral appliances.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | |||
| (Division Sign-Off) | Pen Ruby for MSR | ||
| Division of Anesthesiology, General Hospital | |||
| Infection Control, Dental Devices | |||
| 510(k) Number: | K091300 2-1 |