(43 days)
Not Found
No
The device description focuses on the material properties and intended use as a dental restorative material, with no mention of AI or ML capabilities.
No
The device is a restorative dental material used for fillings, reconstruction, and cosmetic improvements, not for treating a disease or promoting health.
No
The device description indicates that Admira is a universal, light-cured restorative material used for fillings and reconstructions, not for diagnosing conditions.
No
The device description clearly states that Admira is a "restorative material" and is available in "syringes" and "pre-dosed Admira Caps," 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 describes the material being used for direct restoration and repair of teeth. This is a therapeutic and restorative application, not a diagnostic one.
- Device Description: The description focuses on the material's properties for filling cavities, building up cores, and other dental procedures. It doesn't mention any diagnostic function or analysis of 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 information about a patient's health status, disease, or condition
- Using reagents or assays for testing
The device is clearly a dental restorative material used for direct application to the teeth.
N/A
Intended Use / Indications for Use
Admira is a universal, light-cured restorative material. Admira is intended to be used for the following types of restorations in both anterior and posterior teeth:
- · class I-V fillings
- · reconstruction of traumatically affected anteriors
- · facetting of discolored anteriors
- correction of shape and shade to improve asthetic appearance
- · locking or splinting of loose anteriors
- · repairing veneers
- · core build-up under crowns
- composite inlays
Product codes
EBF
Device Description
Admira is a universal, light-cured restorative material based on 3dimensionally stabilized, inorganic/organic polymers (ormocers). Patentprotected ormocer chemistry provides exceptional strength, abrasion resistance, and hard tissue adhesion, while making Admira easy and fast to use. Admira further combines the benefits of silicate glass with the strength, durability, and cosmetic advantages of composites. Admira is suitable for restorations in both anterior and posterior teeth. Admira is used with Admira Bond, a bonding agent that has been specifically designed for the total-etch technique.
Admira is available in both 4gm syringes, and as pre-dosed (0.25gm) Admira Caps (composite application system) for direct intra-oral application. Admira is available in ten tooth shades.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior teeth
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 1 2 2000
Image /page/0/Picture/1 description: The image shows a logo that spells out the word "VOCO". The letters are stylized and geometric. The "V" is an inverted triangle with a small rectangle cut out of the top. The two "O"s are circles with smaller circles cut out of the center, and the "C" is a circle with a portion cut out of it.
| | VOCO GmbH · Postfach 767 · 27457 Cuxhaven | | Anton-Flettner-Straße 1-3
27472 Cuxhaven (Germany)
Telefon: (0 47 21) 719-0
Telefax: (0 47 21) 719-109
Telex: 2 32 202 dent d | |
| -- | ------------------------------------------- | -- | ------------------------------------------------------------------------------------------------------------------------------------------- | -- |
|---|
| Ihr Zeichen
yr ref. | Ihre Nachricht vom
dtd. | Unser Zeichen
our ref. | Datum
date |
| ------------------------ | ---------------------------- | --------------------------- | --------------- |
|---|
510(k) SUMMARY
ADMIRA® (76 EBF)
-
-
- SUBMITTER'S NAME
-
- CONTACT PERSON for VOCO GmbH
-
- DATE THAT 510(k) SUMMARY WAS PREPARED
-
- NAME OF THE MEDICAL DEVICE (Classification / Common / Proprietary)
-
- LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
-
- DESCRIPTION OF THE DEVICE
-
- INTENDED USE OF THE DEVICE
-
- TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES
-
- SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND CONCLUSIONS FROM PRECLINICAL PERFORMANCE STUDIES
-
| 1. SUBMITTER'S NAME |
|---|
| VOCO GmbH |
| Anton-Flettner-Str. 1-3 |
| 27472 Cuxhaven |
| GERMANY |
| Tel: 011-49 47 21 719 0 |
| Fax: 011-49 47 21 719 140 |
1
U.S. REGULATORY CONTACT PERSON FOR VOCO GmbH
Evan Dick, Ph.D. E.G. Dick & Associates 7527 Westmoreland Avenue St. Louis, MO 63105
Tel: (314) 721-0112 (314) 721-7591 Fax:
DATE THAT 510(k) SUMMARY WAS PREPARED
November 30, 1999
| 4. NAME OF THE MEDICAL DEVICE | |
|---|---|
| Classification name | Material, tooth shade, resin |
| (Dental 76 EBF) | |
| Common / usual name | Light-cured dental restorative material |
| Proprietary names | ADMIRA® |
LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
Dyract AP (K973235, DENTSPLY) Solobond M (K980539, VOCO)
2
DESCRIPTION OF THE DEVICE
Admira is a universal, light-cured restorative material based on 3dimensionally stabilized, inorganic/organic polymers (ormocers). Patentprotected ormocer chemistry provides exceptional strength, abrasion resistance, and hard tissue adhesion, while making Admira easy and fast to use. Admira further combines the benefits of silicate glass with the strength, durability, and cosmetic advantages of composites. Admira is suitable for restorations in both anterior and posterior teeth. Admira is used with Admira Bond, a bonding agent that has been specifically designed for the total-etch technique.
Admira is available in both 4gm syringes, and as pre-dosed (0.25gm) Admira Caps (composite application system) for direct intra-oral application. Admira is available in ten tooth shades.
INTENDED USE OF THE DEVICE T
Admira is a universal, light-cured restorative material. Admira is intended to be used for the following types of restorations in both anterior and posterior teeth:
- · class I-V fillings
- · reconstruction of traumatically affected anteriors
- · facetting of discolored anteriors
- correction of shape and shade to improve asthetic appearance
- · locking or splinting of loose anteriors
- · repairing veneers
- · core build-up under crowns
- composite inlays
3
TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES
ADMIRA and DYRACT AP (K973235) are both single-component, light-cured, universal composites composed of silicate glass, polyacrylic/polymethacrylic acid copolymers, photoinitiators, and stabilizers. Both products are used along with a dental bonding agent designed for the total-etch technique.
Image /page/3/Picture/4 description: The image shows the title of a document section. The title is "SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND CONCLUSIONS FROM PRECLINICAL PERFORMANCE STUDIES". The title is in bold and is centered on the page. The number 9 is to the left of the title.
Admira and Admira Bond (the bonding agent for Admira) are formulated from chemical components that are commonly associated with currently marketed dental composite materials.
The chemistry of Admira and Admira Bond raises no new issues or questions that effect safety, effectiveness, or biocompatibility for a dental composite product.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2000
VOCO GmbH c/o Evan G. Dick, Ph.D. VOCO GmbH E.G. Dick & Associates 7527 Westmoreland Avenue St. Louis, Missouri 63105
K994056 Re: Material, Tooth Shade, Resin (Dental 76 EBF) Trade Name: Requlatory Class: II Product Code: EBF November 30, 1999 Dated: November 30, 1999 Received:
Dear Dr. Dick:
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 able beated in 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
5
Page 2 - Dr. Dick
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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) 594-4692. 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
K94056
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K994056
Device Name: Admira
Indications For Use:
Admira is a universal, light-cured restorative material. Admira is intended to be used for the following types of restorations in both anterior and posterior teeth:
- · class I-V fillings
- reconstruction of traumatically affected anteriors
- facetting of discolored anteriors
- · correction of shape and shade to improve asthetic appearance
- · locking or splinting of loose anteriors
- · repairing veneers
- · core build-up under crowns
- · composite inlays
(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)
Nagr (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number
OR Over-The-Counter Use_