(77 days)
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Not Found
No
The provided text describes a dental cement and does not mention any AI or ML capabilities.
No
The device is a permanent cement for dental restorations, which is a supportive material rather than one that treats or cures a disease or condition.
No
Explanation: The intended use of Ceramir Crown & Bridge is for permanent cementation of dental prosthetics, which is a treatment/restorative function, not a diagnostic one.
No
The device is a dental cement, which is a physical material, not software. The 510(k) summary describes its intended use for cementing dental prosthetics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the permanent cementation of dental restorations (crowns, bridges, inlays, onlays, posts). This is a direct application within the body (or on a part of the body) for structural support and restoration.
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Ceramir Crown & Bridge is a dental cement used in vivo (within the body) for a restorative purpose, not for analyzing specimens in vitro (outside the body) for diagnostic information.
N/A
Intended Use / 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)
Product codes
EMA
Device Description
Ceramir Crown & Bridge
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings, rendered in black. The bird is positioned within a circular border. Encircling the bird, along the border, is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a sans-serif font.
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.
1
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 (800) 638-2041 or (301) 796-7100 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
2
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
Page 9(47)