CERAMIR CROWN & BRIDGE

K100510 · Doxa AB · EMA · Mar 25, 2010 · Dental

Device Facts

• Record ID: K100510
• Device Name: CERAMIR CROWN & BRIDGE
• Applicant: Doxa AB
• Product Code: EMA · Dental
• Decision Date: Mar 25, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

Ceramir Crown & Bridge is intended for the permanent cementation of - Porcelain Fused to Metal Crowns and Bridges . - Metal (gold etc.) crowns and bridges . - . Gold inlays and onlays - . Cast or prefabricated metal posts - . Strengthened core all-zirconia or all-alumina ceramic crowns and bridges

Device Story

Ceramir Crown & Bridge is a hybrid glass ionomer-ceramic dental cement used for permanent luting of dental restorations. The device consists of powder and liquid components supplied in a capsule format. The capsule is activated and mixed in a mechanical mixer prior to clinical application by a dental professional. The cement acts as a bonding agent between the tooth structure and the restoration (crowns, bridges, inlays, onlays, or posts). It provides a stable, biocompatible interface to secure the restoration, potentially improving long-term retention and clinical outcomes for patients requiring restorative dental procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing demonstrating that the physical properties and biocompatibility of the capsule-mixed cement are equivalent to the predicate device.

Technological Characteristics

Hybrid glass ionomer-ceramic dental cement. Supplied as powder and liquid in a pre-filled capsule. Activated and mixed via mechanical mixer. Class II device (21 CFR 872.3275).

Indications for Use

Indicated for permanent cementation of dental restorations including porcelain-fused-to-metal crowns/bridges, metal crowns/bridges, gold inlays/onlays, cast/prefabricated metal posts, and strengthened core all-zirconia or all-alumina ceramic crowns/bridges.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• XeraCemTM (K081405)

Submission Summary (Full Text)

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K100510

# Doxa

## 13 510(k) Summary

MAR 2 5 2010

#### 13.1 Submitter and manufacturer

Doxa Dental AB Axel Johanssons qata 4-6 SE 754 51, Uppsala, Sweden Phone: [phone]: Fax: [phone]

Contact: Margareth Jorvid, Doxa Dental AB, Axel Johanssons gata 4-6 SE 754 51, Uppsala, Sweden Phone: [phone] Fax: [phone] E-mail: [e-mail]

#### 13.2 Date of Submission

February 18th, 2010

#### 13.3 Device Name

Trade name Ceramir® Crown & Bridge

Common or Usual Name Dental Cement

#### Classification name

Dental cement other than zinc oxide-eugenol (21 CRF 872.3275)

#### Product Code

EMA

#### 13.4 Predicate Devices

| Trade name | 510(k) holder | 510(k) No. |
|------------|----------------|------------|
| XeraCemTM | Doxa Dental AB | K081405 |

#### 13.5 Indications for Use

Ceramir Crown & Bridge is intended for the permanent cementation of

- Porcelain Fused to Metal Crowns and Bridges .
- Metal (gold etc.) crowns and bridges .
- . Gold inlays and onlays
- . Cast or prefabricated metal posts

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- . Strengthened core all-zirconia or all-alumina ceramic crowns and bridges
#### 13.6 Technological characteristics

Ceramir Crown & Bridge is a hybrid glass ionomer-ceramic dental cement. The liquid and powder are packed are in a capsule format. The capsule is activated and the powder and liquid is mixed in a mixer before use.

#### 13.7 Performance Data

Ceramir Crown & Bridge is technologically identical to its predicate device. The powder and liquid are identical. The proportion between amount of powder and amount of liquid is the same in the mixed cement. The packaging format and mixing differs; XeraCem is hand mixed while Ceramir Crown & Bridge is packed and mixed in a capsule format. Studies have proven the properties, including biocompatibility of the cement to be substantially equivalent to the predicate device.

#### 13.8 Substantial Equivalence

Ceramir Crown & Bridge is as safe and effective as the predicate device and performs as well as the predicate device. Ceramir Crown & Bridge has the same intended use and technological characteristics as its predicate device.

In summary, the dental luting cement Ceramir Crown & Bridge described in this submission is, in our opinion, substantially equivalent to the predicate device, XeraCem.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Margareth Jorvid Regulatory Affairs Doxa Dental AB Axel Johanssons, Gata 4-6 Uppsala Sweden SE-754 51

MAR 2 5 2010

Re: K100510

Trade/Device Name: Ceramir Crown & Bridge Regulation Number: 21CFR 872,3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 19, 2010 Received: March 22, 2010

Dear Ms. Jorvid:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2- Ms. Jorvid

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K100510

### 16.4 Attachment 4: Indications for Use, Ceramir Crown & Bridge

# Indications for Use, Ceramir Crown & Bridge

510(k) Number:

Device Name: Ceramir Crown & Bridge

Indications for Use:

Ceramir Crown & Bridge is intended for the permanent cementation of

- Porcelain Fused to Metal Crowns and Bridges ●
- Metal (gold etc.) crowns and bridges .
- Gold inlays and onlays
- Cast or prefabricated metal posts
- Strengthened core all-zirconia or all-alumina ceramic crowns and bridges ●

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R&Atoons for Dr KPMuller

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k100510

Special 510(k) Ceramir Crown & Bridge