(31 days)
No
The summary describes a dental cement and its intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a dental cement intended for permanent cementation, which is a restorative rather than therapeutic function.
No
The device is a dental cement used for permanent cementation of various dental restorations, not for diagnosing conditions.
No
The device is a dental cement, which is a physical material, not software. The description clearly states it is a "hybrid glass ionomer-ceramic dental cement" in a "capsule format."
Based on the provided information, Ceramir Crown & Bridge is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for the permanent cementation of various dental restorations (crowns, bridges, inlays, onlays, posts). This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The description details a dental cement used for bonding, which aligns with its restorative function.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on properties and biocompatibility related to its function as a cement, not on diagnostic accuracy.
IVD devices are used to examine specimens from the human body to provide information for diagnostic purposes. Ceramir Crown & Bridge is a material used in the body for a restorative procedure.
N/A
Intended Use / 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
Product codes
EMA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies have proven the properties, including biocompatibility of the cement to be substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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: +46 18 478 000: Fax: +46 478 001
Contact: Margareth Jorvid, Doxa Dental AB, Axel Johanssons gata 4-6 SE 754 51, Uppsala, Sweden Phone: +46 70 519 2640 Fax: +46 18 478 2001 E-mail: Margareth.jorvid@lsmgroup.se
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
1
- . 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.
2
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.
3
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 (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
Enclosure
4
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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