ADMIRA

K994056 · Voco GmbH · EBF · Jan 12, 2000 · Dental

Device Facts

• Record ID: K994056
• Device Name: ADMIRA
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: Jan 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Admira is a universal, light-cured dental restorative material based on 3D-stabilized inorganic/organic polymers (ormocers). It combines silicate glass with composite properties to provide strength, abrasion resistance, and hard tissue adhesion. Used by dentists in clinical settings for anterior and posterior tooth restorations. Available in syringes or pre-dosed caps for direct intra-oral application. Requires use with a bonding agent (Admira Bond) via total-etch technique. Material is light-cured to harden, providing structural restoration, aesthetic correction, or splinting for teeth. Benefits include improved durability and aesthetics for dental patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and chemical composition comparison to predicate devices.

Technological Characteristics

Universal, light-cured restorative material based on 3D-stabilized inorganic/organic polymers (ormocers). Contains silicate glass, polyacrylic/polymethacrylic acid copolymers, photoinitiators, and stabilizers. Available in 4gm syringes or 0.25gm pre-dosed caps. Ten tooth shades available. Requires light-curing and total-etch bonding agent.

Indications for Use

Indicated for patients requiring dental restorations in anterior or posterior teeth, including class I-V fillings, reconstruction of traumatically affected anteriors, facetting of discolored anteriors, correction of shape/shade, locking/splinting of loose anteriors, repairing veneers, core build-up under crowns, and composite inlays.

Regulatory Classification

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.

Predicate Devices

• Dyract AP (K973235)
• Solobond M (K980539)

Submission Summary (Full Text)

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#### JAN 1 2 2000

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| | VOCO GmbH · Postfach 767 · 27457 Cuxhaven | | Anton-Flettner-Straße 1-3<br>27472 Cuxhaven (Germany)<br>Telefon: [phone]<br>Telefax: (0 47 21) 719-109<br>Telex: 2 32 202 dent d | |
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K994056

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# 510(k) SUMMARY

ADMIRA® (76 EBF)

- - 1. SUBMITTER'S NAME
- 2. CONTACT PERSON for VOCO GmbH
- 3. DATE THAT 510(k) SUMMARY WAS PREPARED
- 4. NAME OF THE MEDICAL DEVICE (Classification / Common / Proprietary)
- 5. LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
- 6. DESCRIPTION OF THE DEVICE
- 7. INTENDED USE OF THE DEVICE
- 8. TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES
- 9. SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND CONCLUSIONS FROM PRECLINICAL PERFORMANCE STUDIES

| 1. SUBMITTER'S NAME |
|-------------------------------------------------------------------|
| VOCO GmbH<br>Anton-Flettner-Str. 1-3<br>27472 Cuxhaven<br>GERMANY |
| Tel: [phone]<br>Fax: [phone] |

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U.S. REGULATORY CONTACT PERSON FOR VOCO GmbH

Evan Dick, Ph.D. E.G. Dick & Associates 7527 Westmoreland Avenue St. Louis, MO 63105

Tel: [phone] [phone] Fax:

DATE THAT 510(k) SUMMARY WAS PREPARED

November 30, 1999

| 4. NAME OF THE MEDICAL DEVICE | |
|-------------------------------|-------------------------------------------------|
| Classification name | Material, tooth shade, resin<br>(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)

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#### 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

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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.

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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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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_