(94 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a dental cement, with no mention of AI or ML technologies.
No.
XeraCem is a dental cement used for the permanent cementation of crowns, bridges, inlays, onlays, and posts. It is used to affix pre-fabricated dental structures, not to treat a disease or condition itself.
No
The device is a dental cement intended for permanent cementation of various dental restorations. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly states that XeraCem is a hand-mixed cement consisting of a powder and a liquid, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that XeraCem is for the permanent cementation of dental restorations (crowns, bridges, inlays, onlays, posts). This is a dental procedure performed on a patient's teeth.
- Device Description: The description details a dental cement used for bonding.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVDs are used to perform tests outside the body on biological samples to gain information about a person's health status. XeraCem is a material used within the body for a restorative dental purpose.
N/A
Intended Use / Indications for Use
XeraCem is intended for the permanent cementation of
- Porcelain Fused to Metal Crowns and Bridges .
- Metal (gold etc.) crowns and bridges .
- Gold inlays and onlays .
- . Prefabricated metal and cast posts
- . Prefabricated metal provisional crowns
- . All-zirconia or all-alumina ceramic crowns and bridges
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
XeraCem is a hybrid between glass ionomer cement and ceramic cement based on calcium aluminate. It combines the advantages of glass ionomer cements with those of calcium aluminum based cements. XeraCem is a hand mixed cement and consists of a powder (XeraCem powder) and a liquid (XeraCem liquid).
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)
XeraCem has been evaluated and passed biocompatibility testing of cytotoxicity, genotoxicity, irritation, and sensitization. In all instances, XeraCem functioned as intended and the performance observed was as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
5. 510(k) Summary, XeraCem™
5.1. Submitter
Jonathan S. Kahan, Esg. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C., 20004 Phone: (202) 637 5794 Facsimile: (202)637 5910
AUG 2 1 2008
Date Prepared: May 19, 2008
5.2. Device Name and Name/Address: of Sponsor
XeraCem™ Doxa Dental AB Axel Johanssons gata 4-6, SE 754 51 Uppsala, Sweden
Common or Usual Name
Dental Cement
Classification name
Dental cement other than zinc oxide-eurgenol (21 CRF 872.3275)
Product Code
EMA
5.3. Predicate Devices
| Trade name | 510(k) holder | 510(k) No. |
|---|---|---|
| KetacTM Cem Maxicap | ESPE GMBH | K897188 |
| DoxaDentTM | Doxa Certex AB | K011839 |
5.4. Intended Use/Indications for Use
XeraCem is a hybrid between glass ionomer cement and ceramic cement based on calcium aluminate. It combines the advantages of glass ionomer cements with those of calcium aluminum based cements. XeraCem is a hand mixed cement and consists of a powder (XeraCem powder) and a liquid (XeraCem liquid).
XeraCem is intended for the permanent cementiation of
- Porcelain Fused to Metal Crowns and Bridges .
- Metal (gold etc.) crowns and bridges .
- Gold inlays and onlays .
- . Prefabricated metal and cast posts
1
- . Prefabricated metal provisional crowns
- . All-zirconia or all-alumina ceramic crowns and bridges
5.5. Technological characteristics
XeraCem is a hybrid glass ionomer-ceramic dental cement, reconstituted prior to use by hand mixing the XeraCem powder with the XeraCern liguid.
5.5. Performance Data
XeraCem is technologically identical to the previously cleared Ketac Cem Maxicap. Various physical and mechanical studies were conducted to compare XeraCem the predical realidas XeraCem has been evaluated and passed biocompatibility testing of cytotoxicity, genotoxicity, irritation, and sensitization. In all instances, XeraCem functioned as intended and the performance observed was as expected.
5.6. Substantial Equivalence
XeraCem is as safe and effective as the predicate devices. XeraCem has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. Thus, XeraCem is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Doxa Dental AB C/o Mr. Jonathan Kahan Regulatory Counsel Hogan & Hartson LLP 555 Thirteenth Street, NW Columbia Square Washington, DC 20004
AUG 2 1 2008
Re: K081405
Trade/Device Name: XeraCem™ Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 18, 2008 Received: August 18, 2008
Dear Mr. Kahan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Kahan
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu S. Lin, Ph.D.
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use, XeraCem™
510(k) Number (if known):
5081405
Device Name: XeraCem™
Indications for Use:
XeraCem is intended for the permanent cementation α=
- Porcelain Fused to Metal Crowns and Bridges .
- Metal (gold etc.) crowns and bridges ●
- Gold inlays and onlays .
- Prefabricated metal and cast posts
- Prefabricated metal provisional crowns
- All-zirconia or all-alumina ceramic crowns and bridges
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Ower-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)
Susan Graves
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081005
Fage 1 of 1
- Indications for Use, XeraCem
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