(77 days)
No
The description focuses on the material properties and intended use of a dental composite, with no mention of AI or ML.
Yes
The device is described as a "filling material for small restorations" and a "lining material in the base of large restorations" and is intended for use in dental restorations, which are therapeutic interventions.
No
This device is a filling material for dental restorations, not a device used to diagnose a medical condition.
No
The device description clearly states it is a "flowable composite material" and a "methacrylate (BisGMA) based material," indicating it is a physical substance used in dental procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for filling small restorations, sealing occlusal surfaces, and lining large restorations in the mouth. This is a direct application to the patient's tooth.
- Device Description: The description details a material used for dental restorations, applied directly to the tooth.
- Anatomical Site: The anatomical site is the tooth.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
CONFORM™ is a material applied in vivo (within the living body) for restorative purposes, not for testing specimens in vitro (outside the living body).
N/A
Intended Use / Indications for Use
CONFORM™ is a light cured (free radical polymerization), flowable composite material, designed for use as a filling material for small restorations, a sealant material for occlusal surfaces, or a lining material in the base of large restorations.
CONFORM™ is a versatile composite material which, when utilized properly, provides a strong, wear resistant material for dental restorations. CONFORM™ can also be used as the initial filled layer or liner of a cavity restoration. When used as a liner, the material provides a strong base that assures the mechanical interface between the bonded tooth substrate and a highly filled composite are optimal. CONFORM™ is compatible with all other methacrylate based dental materials.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
CONFORM™ is a light activate (photo initiated, free radical polymerization), flowable hybrid composite material designed to act as a filling material in small restorations or as a liner material for larger restorations. CONFORM™ has been designed to provide a flowable material with a high level of thixotropic behavior. The material also contains fillers to optimize the cured strength and radiopacity properties.
CONFORM™ is a methacrylate (BisGMA) based material that has been designed to work effectively with methacrylate based adhesives and composites currently sold into the dental market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
CONFORM™ has similar handling to the AELITEFLO® (510K number K955292, Bisco, Inc.) composite. From the physical testing observations and analysis, including diametric tensile strength and compressive strength, we suggest that CONFORM™MM is substantially equivalent to AELITEFLO® (510K number K955292, Bisco, Inc.).
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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
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OCT 1 3 2006
510 (K) SUMMARY
As Required by the Safe Medical Devices Act of 1990
Apex Dental Materials, Inc. 23329 Mallard Court Deer Park, IL 60010 Phone: (877) 273-9123
July21st, 2006 510 (K) Submission Date: Chris Kulton Contact Person: Device Name: CONFORM™ Trade Name: Material, Tooth Shade, Resin Common Name: Tooth Shade Resin Material, per 21 CFR parts 872.3690 Classification Name: Classification: Regulatory Class: 2
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE
EBF
PREDICATE DEVICE
Product Code:
AELITEFLO® (Bisco, Inc. K955292) is a flowable composite material designed to act as a
cavity filling or lining material. This system is applied directly to bonded tooth surfaces to
effectively replace removed tooth structure.
AELITEFLO® (Bisco, Inc. K955292) is a methacrylate based composite material filled with
various inorganic glasses to provide strength, wear and radiopacity characteristics.
AELITEFLO® is a single paste material that is used directly with dental bonding systems. It
510K Submission for CONFORM™ Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010
Page 11 of 14
1
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hardens by a photo initiated polymerization mechanism employing a light initiator, and a chemical activator.
Summary continued:
DESCRIPTION OF APPLICATION DEVICE
CONFORM™ is a light activate (photo initiated, free radical polymerization), flowable hybrid composite material designed to act as a filling material in small restorations or as a liner material for larger restorations. CONFORM™ has been designed to provide a flowable material with a high level of thixotropic behavior. The material also contains fillers to optimize the cured strength and radiopacity properties.
CONFORM™ is a methacrylate (BisGMA) based material that has been designed to work effectively with methacrylate based adhesives and composites currently sold into the dental market.
INTENDED USES OF APPLICANT DEVICE
CONFORM™ is a light-cured composite with flow characteristics that make it ideal for Class V restorations, as well as Class III, and small Class IV restorations. Other uses of this material are as a liner for Class I and II restorations, pit and fissure sealants, the repair of marginal defects, small core build-ups, porcelain repair, porcelain veneer cementation or as a flowable composite for bonding splints into place.
- Class V .
- Class III .
- Cavity Liner .
510K Submission for CONFORM™ Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010
Page 12 of 14
2
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- Pit and Fissure sealant ●
- Porcelain repair .
- . Margin repair
- Core build ups .
- . Buccal repair
Summary continued:
PERFORMANCE CHARACTERISTICS and CONCEPTS
CONFORM™ has similar handling to the AELITEFLO® (510K number K955292, Bisco, Inc.) composite. From the physical testing observations and analysis, including diametric tensile strength and compressive strength, we suggest that CONFORM™MM is substantially equivalent to AELITEFLO® (510K number K955292, Bisco, Inc.). Along with this we would suggest the individual components of CONFORM™ are long time industry standards and are utilized in numerous dental composite products currently marketed in the United States (see Confidential Formulation Details on page 5).
| Equivalent Product and Manufacturer | Corresponding 510(k) Number |
|---|---|
| AELITEFLO® (Bisco, Inc.) | K955292 |
| PERMAFLO® (Ultradent Products Inc.) | K974413 |
510K Submission for CONFORM™ Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
0C1 1 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chris Kulton Apex Dental Materials, Incorporated 23329 Mallard Court Dear Park, Illinois 60010
Re: K062157
Trade/Device Name: ConformTM Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: July 21, 2006 Received: July 31, 2006
Dear Mr. Kulton:
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 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.
4
Page 2 – Mr. Chris Kulton
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/cdrh/industry/support/index.html.
Sincerely yours.
Scudette Y. Michelini Ond
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
5
Indications for Use
510(K) Number (if known):
Device name:
CONFORMIM
Indications For Use:
CONFORM™ is a light cured (free radical polymerization), flowable composite material, designed for use as a filling material for small restorations, a sealant material for occlusal surfaces, or a lining material in the base of large restorations.
CONFORM™ is a versatile composite material which, when utilized properly, provides a strong, wear resistant material for dental restorations. CONFORM™ can also be used as the initial filled layer or liner of a cavity restoration. When used as a liner, the material provides a strong base that assures the mechanical interface between the bonded tooth substrate and a highly filled composite are optimal. CONFORM™ is compatible with all other methacrylate based dental materials.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRL, Office of Device Evaluation (ODE)
| Prescription use X (Per 21 CFR 801.109 | OR |
| ion of Anesthesiology, General Hospital, Over, The- Counter Use | |
| ion Control, Dental Devices | |
| Number: K 062157 (Optional Format 1-2-96) |
510K Submission for CONFORM™
Page 4 of 14
Apex Dental Materials,
23329 Mallard Court
Deer Park, IL 60010