ADMIRA FLOW

K011756 · Voco GmbH · EBF · Jul 18, 2001 · Dental

Device Facts

• Record ID: K011756
• Device Name: ADMIRA FLOW
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: Jul 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Admira Flow is a light-curing and radiopaque filling material. Admira Flow is intended to be used for the following types of restorations in both anterior and posterior teeth: - fillings with minimally invasive preparation technique . - filling small cavities and sealing extended fissures . - blocking out undercuts ◆ - lining or coating cavity walls . - Class III-V filings, including V-shaped defects and cervical caries . - repairing fillings and veneers . - luting of translucent prosthetic pieces (e.g., porcelin-only-crowns)

Device Story

Admira Flow is a flowable, light-curing, radiopaque dental restorative material based on ormocer (organically modified ceramic) composite technology. It consists of inorganic micro-particles (0.7 um) and fumed silica (0.05 um) in a resin matrix. Used by dentists in clinical settings for anterior and posterior tooth restorations. Applied via 1.8gm syringes or single-use 0.25gm caps. Cured using blue halogen light. Provides high-gloss polish, durability, and color stability. Assists clinicians in restoring tooth structure, sealing fissures, and luting prosthetic pieces.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Flowable, light-curing, radiopaque dental composite. Composition: silicate glass, methacrylate polymers/copolymers, photoinitiators, stabilizers, inorganic micro-particles (0.7 um), and fumed silica (0.05 um). Ormocer-based chemistry. Form factor: 1.8gm syringes or 0.25gm single-use caps. Curing source: blue halogen light.

Indications for Use

Indicated for dental patients requiring anterior or posterior tooth restorations, including minimally invasive fillings, small cavity filling, fissure sealing, undercut blocking, cavity wall lining/coating, Class III-V restorations (including V-shaped defects and cervical caries), repair of fillings/veneers, and luting of translucent prosthetic pieces.

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

• ADMIRA (K994056, VOCO)

Submission Summary (Full Text)

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JUL 1 82001

VOCO GmbH · P.O.B./ Postfach 767 · D-27457 Cuxhaven (Germany)

Image /page/0/Picture/1 description: The image shows a logo with four characters. The first character is a triangle with a line above it. The second and fourth characters are circles with a smaller circle in the middle. The third character is a circle with a cone shape cut out of it.

Anton-Flettner-Straße 1-D-27472 Cuxhaven (Germany)

Telefon: [phone] - 0 intl.: [phone]

Telefax: (0 47 21) 7 19 - 1 09 intl .: [phone] - 1 40

Internet: http://www.voco.de e-mail: [e-mail]

Ihr Zeichen yr. ref.

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Ihre Nachricht vom dtd.

Unser Zeicher our ref.

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Datum date

### 510((k) SUMMARY

#### ADMIRA FLOW® (76 EBF)

- Submitter's Name 1.
- Contact Person For VOCO GmbH 2.

20 201 102 07

- Date that 510(k) Summary Was Prepared 3.
- Name of the Medical Device (Classification / Common / Proprietary) 4.
- Legally Marketed Devices To Which Substantial Equivalence Is Claimed ട.
- Description of the Device റ.
- 7. Intended Use of the Device
- Technological Comparison Between Subject and Predicate Devices 8.
- Summary of Preclinical Performance Studies and Conclusions From த. Preclinical Performance Studies

SUBMITTER'S NAME VOCO GmbH Anton-Flettner-Str. 1-3 27472 Cuxhaven GERMANY 011-49-47 21 719 0 Tel: [phone] Fax:

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| 2. U.S. REGULATORY CONTACT PERSON FOR VOCO GmbH |
|----------------------------------------------------------------------------------------------|
| Evan Dick, Ph.D<br>E.G. Dick & Associates<br>7527 Westmoreland Avenue<br>St. Louis, MO 63105 |
| Tel: [phone]<br>Fax: [phone] |

DATE THAT510(k) SUMMARY WAS PREPARED

June 4, 2001

5.

| 4. | NAME OF THE MEDICAL DEVICE | |
|---------------------|-------------------------------------------------|--|
| Classification name | Material, tooth shade, resin<br>(Dental 76 EBF) | |
| Common / usual name | Light-curing dental restorative material | |
| Proprietary name | ADMIRA FLOW | |

LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL
EQUIVALENCE IS CLAIMED

ADMIRA (K994056, VOCO)

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#### ESCRIPTION OF THE DEVICE

Admira Flow is a flowable, light-curing, and radiopaque filling material based on ormocer composite technology. Admira Flow is suitable for restorations in both anterior and posterior teeth. Admira Flow is a low viscosity composite that offers excellent wetting and adhesion. Patent-protected ormocer chemistry provides excellent strength, abrasion resistance, and adhesion to the tooth structure, while making Admira Flow easy and fast to use. Admira Flow contains 64% (by yolume. 54% by weight) inorqanic micro-particles (0.7 um) and fumed silica (0.05 um). Admira Flow cures under halogen light (blue light) and can be polished to a high gloss that is durable and color stable.

Admira Flow is available both as 1.8gm syringes and as single-use Admira Flow Caps (0.25gm) for direct intra-oral application. Admira Flow is available in six shades (A1, A2, A3, A3.5. A4, OA3.5).

#### INTENDED USE OF THE DEVICE

Admira Flow is a light-curing and radiopaque filling material. Admira Flow is intended to be used for the following types of restorations in both anterior and posterior teeth:

- fillings with minimally invasive preparation technique .
- filling small cavities and sealing extended fissures .
- blocking out undercuts ◆
- lining or coating cavity walls .
- Class III-V filings, including V-shaped defects and cervical caries .
- repairing fillings and veneers .
- luting of translucent prosthetic pieces (e.g., porcelin-only-crowns)

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### HNOLOGICAL COMPARISON BETWEEN SUBJECT AND REDICATE DEVICES

Admira Flow and Admira (K994056, VOCO) are both single component, lightcuring restorative materials that are composed of silicate glass, methacrylate polymers and copolymers, photoinitiators, and stabilizers.

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 all caps.

Admira Flow is formulated from chemical components that are commonly associated with currently marketed dental composite materials.

The chemistry of Admira Flow raises no new issues or questions that effect safety, effectiveness, or biocompatibility for 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 and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2001

VOCO GMBH C/O Mr. Evan Dick President E.G. Dick & Associates 7527 Westmoreland Avenue Saint Louis, Missouri 63105

K011756 Re : Trade/Device Name: Admira Flow Regulation Number: 872.3690 Requlatory Class: II Product Code: EBF Dated: June 6, 2001 Received: June 6, 2001

Dear Mr. Dick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marroo 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). 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 reqistration, 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 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

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#### Page 2 - Mr. Dick

concerning your device in the Federal Register. Please note: concerning your devros in and ification submission does this response to your promobility have under sections 531 not arrect any obingation devices under the Electronic Chrough 342 or the nec-rol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as Inis icceer wire as 0 (k) premarket notification. The FDA described in your sion, promience of your device to a legally Finding of Bubbeanelasion in a classification for your marketed predicate device rubates to proceed to the market.

If you desire specific advice for your device on our labeling II you desire bpccirie additionally 809.10 for in regulacion (ir c devices), please contact the Office of Compliance at [phone]. Additionally, for questions on Compliance at (301) 394 issing of your device, please contact che promocron and adversions of [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance oblained from the Drvibion of Billing [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Ulatowski Timothy A. 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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# 756

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Admira Flow Device Name:

Indications For Use:

Admira Flow is a light-curing and radiopaque filling material. Admira Flow is / lamira i low to a light outher following types of restorations in both anterior and posterior teeth:

- fillings with minimally invasive preparation technique .
- filling small cavities and sealing extended fissures .
- blocking out undercuts .
- lining or coating cavity walls .
- Class III-V filings, including V-shaped defects and cervical caries .
- repairing fillings and veneers
- luting of translucent prosthetic pieces (e.g., porcelin-only-crowns)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use

OR

Over-The-Counter

(as per 21 CFR 801.109)

Susan Rurr

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 人公儿 510(k) Number _