CERAMIR CROWN & BRIDGE

K113040 · Doxa Dental AB · EMA · Dec 28, 2011 · Dental

Device Facts

• Record ID: K113040
• Device Name: CERAMIR CROWN & BRIDGE
• Applicant: Doxa Dental AB
• Product Code: EMA · Dental
• Decision Date: Dec 28, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ceramir Crown & Bridge is intended for the permanent cementation of - Metal and Porcelain Fused to Metal Crowns and Bridges . - Gold inlays and onlays . - Cast or prefabricated metal posts . - Cast or prefabricated metal crowns and bridges suitable for conventional cementation (e.g. high strength ceramics such as zirconia, alumina, and lithium disilicate)

Device Story

Ceramir Crown & Bridge is a dental cement used for permanent fixation of various prosthetic restorations including crowns, bridges, inlays, onlays, and posts. It is applied by dental professionals in a clinical setting. The device functions as a luting agent to bond restorative materials to prepared tooth structures. It provides a stable, permanent cementation interface, facilitating the restoration of dental function and aesthetics for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental cement (Product Code EMA). Classified under 21 CFR 872.3275(b).

Indications for Use

Indicated for permanent cementation of metal, porcelain-fused-to-metal, gold inlays/onlays, metal posts, and high-strength ceramic (zirconia, alumina, lithium disilicate) crowns and bridges in patients requiring dental restorations.

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.

Submission Summary (Full Text)

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

DEC 2 8 2011

Ms. Margareth Jorvid Doxa Dental AB Axel Johanssons Gata 4-6 SE-754 51 Uppsala SWEDEN

Re: K113040

Trade/Device Name: Ceramir Crown & Bridge Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Ceramic Regulatory Class: II Product Codes: EMA Dated: October 11, 2011 Received: October 12, 2011

Dear Ms. Jorvid:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becomer mined 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 Incelsiale comments, or to that been reclassified in accordance with the provisions of Amendinents, or to de rioss that neve Act (Act) that do not require approval of a premarket the rederal I vou, Drug, und Oomen's , therefore, market the device, subject to the general approval application (1 Mr.). I ou seneral controls provisions of the Act include confors provisions of the ristration, listing of devices, good manufacturing practice, requirences for annual registration, shranding 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 (FMA), It may be subject to adultions, Title 21, Parts 800 to 898. In device can be found in the Oods of Features 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 Please be auvised that I DA s issualled of a basedant in the complies with other requirements mean that FDA nas made a deceminations administered by other Federal agencies. bit the Act of ally I ederal statutes and reguirements, including, but not limited to: registration 1 ou inust comply with an the Net over 801); medical device reporting allu listing (21 OF R F ar 807), lated adverse events) (21 CFR 803); good manufacturing of me and (reporting of medical device related as resems (QS) regulation (21 CFR Part 820);
practice requirements as set forth in the quality systems (QS) regulation (21 cf 12 cf 1 practice requirements as set rerul in the padiation 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), 11 you desire specific aw fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices prease go to http://www.for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compilance: "Anso, prease note to togen. For questions regarding the reporting of premarket nothrounder 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 1 ou may obtain other gener getting al 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

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## Doxa

## Indication for use for new Ceramir Crown & Bridge (described in 4.2 this submission)

510(k) Number (if known):

Device Name: Ceramir Crown & Bridge

Indications for Use:

Ceramir Crown & Bridge is intended for the permanent cementation of

- Metal and Porcelain Fused to Metal Crowns and Bridges .
- Gold inlays and onlays .
- Cast or prefabricated metal posts .
- Cast of prefabriodical metally provins and bridges suitable for conventional ● righ Strength og. zirconia, alumina, and lithium disilicate)

Prescription Use × (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)

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

1411 3040 Page 1 of 1 510(k) Number:

ge 1 of 1

510(k) Ceramir Crown & Bridge

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