(103 days)
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No
The document describes a dental composite filling material and its intended uses, with no mention of AI or ML technology.
Yes
The device is indicated for direct filling of cavities, reconstruction of natural enamel and dentine, and other dental repair and restoration purposes, which are considered therapeutic interventions.
No
The device is a composite filling material used for restorative dental procedures, not for diagnosing conditions.
No
The device description and intended use clearly indicate a composite material used for dental restorations, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended uses listed for the SYNERGY Composite System are all related to direct application and restoration within the mouth, on teeth.
- The device description and intended uses do not mention any analysis of biological samples. The product is a composite material for dental restorations.
Therefore, this device falls under the category of a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SYNERGY Shades (enamel) A1/D2, A2/B2, A3/D3, A4/M5, A3.5/B3, C2/C3 is indicated for:
- direct filling of class I, II, III, IV and V cavities
- reconstruction of natural enamel and dentine
- reconstruction of fractured anteriors
- sealing of extended fissure in molars and premolars
- stabilization of mobile anteriors
- repair of veneer facings
- fixation of splints
- bonded bridges
- esthetic
Synergy Compact (dentin) A2/B2, A3/D3, A3.5/B3 is specifically indicated for:
- core reconstruction in highly esthetic class I, II, III restorations, which are subsequently covered with a more translucent material
- direct class V fillings
- direct filling of opaque teeth
- palatinal of class IV restorations
- core build-ups
- shape and color corrections to improve esthetics
SYNERGY Transparent is specifically indicated for:
- reconstruction of incisal edges in class IV fillings
- translucent surface layers in all classes
- covering characterizations
Super White is especially indicated for:
- restoration of whitened teeth
- restoration of deciduous teeth
- characterization of chalk spots
- veneering of anteriors
Product codes
EBF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 1998
Mr. H.J. Vogelstein Official Correspondent Colténe/Whaledent Incorporated 750 Corporate Drive Mahwah, New Jersey 07430
Re : K974465 Synergy Trade Name: Requlatory Class: II Product Code: EBF February 12, 1998 Dated: February 13, 1998 Received:
Dear Mr. Vogelstein:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Vogelstein
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cresciotti/foe
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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02 PAGE j p
| Page | 1 of 1 |
|---|---|
| 510(k) Number (if known): | K979465 |
| Device Name: | SYNERGY Composite System. |
Coltène/Whaledent Inc.
750 Corporate Drive
Mahwah, NJ 07430
Telephone: 201-512-8000
HV971558h-1
SYNERGY 510(k) Submission
SYNERGY Composite System
Indications For Use
SYNERGY Shades (enamel) A1/D2, A2/B2, A3/D3, A4/M5, A3.5/B3, C2/C3 is indicated for:
- direct filling of class I, II, III, IV and V cavities
- reconstruction of natural enamel and dentine
- reconstruction of fractured anteriors
- sealing of extended fissure in molars and premolars
- stabilization of mobile anteriors
- repair of veneer facings
- fixation of splints
- bonded bridges
- esthetic
Synergy Compact (dentin) A2/B2, A3/D3, A3.5/B3 is specifically indicated for:
- core reconstruction in highly esthetic class I, II, III restorations, which are
subsequently covered with a more translucent material - direct class V fillings
- direct filling of opaque teeth
- palatinal of class IV restorations
- core build-ups
- shape and color corrections to improve esthetics
SYNERGY Transparent is specifically indicated for:
- reconstruction of incisal edges in class IV fillings
- translucent surface layers in all classes
- covering characterizations
Super White is especially indicated for:
- restoration of whitened teeth
- restoration of deciduous teeth
- characterization of chalk spots
- veneering of anteriors
Contra-indications:
- If allergies exist to any of the components of coltene® SE Composite.
- If the site cannot be isolated after enamel etching and during application
and curing of coltène® SE Composite. - If oral hygiene is poor.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) | |
|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K974465 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use | |
|---|---|---|---|
| --------------------------------------- | ---------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)
(Optional Formal 1-2-96)