(101 days)
Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis) Final cementation of post and screws Final cementation of ceramic, composite or metal restorations on implant abutments Cementation of abutments made of Lava™ zirconium oxide ceramic
Unicem Aplicap/Maxicap cements are dual-curing, self-adhesive resin cements available in two single dose delivery systems in capsules (K020256). They are used for the permanent cementation of indirect restorations made of ceramic, composite, or metal, and for posts and screws. Bonding and conditioning of the prepared tooth structure are not necessary with Unicem Aplicap™ and Maxicap™M. Unicem Aplicap™ and Unicem Maxicap™ release fluoride ions, and are available in various shades. Unicem Aplicap™ and Unicem Maxicap™ contain bifunctional (meth)acrylate.
The provided text is a 510(k) summary for a dental cement (Unicem Aplicap/Maxicap). It focuses on establishing substantial equivalence to predicate devices and expanding indications for use, primarily through comparison of performance data and biocompatibility testing. The document does not contain information on clinical studies that would involve acceptance criteria, test sets, ground truth establishment, or human reader performance as typically seen with AI/CADe devices.
Therefore, many of the requested details cannot be extracted from this specific document.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or a direct performance table as would be found for an AI/CADe device. It generally states that "the comparison for performance data and indications for use shows that Unicem Aplicap™ /Maxicap™ is substantially equivalent to its predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission is for a dental cement, not an AI/CADe device that uses a "test set" of clinical data in this manner. The "performance data" mentioned likely refers to physical and chemical properties of the cement, not clinical image data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically understood for AI/CADe devices (e.g., expert consensus on medical images) is not relevant to this dental cement submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of clinical image interpretation. For dental cements, "ground truth" would likely refer to established physical and chemical properties and their compliance with relevant international standards, which are not detailed here beyond a general statement of "biocompatibility testing."
8. The sample size for the training set
Not applicable. This is not an AI/CADe device, and therefore does not have a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
APR - 8 2010
Submitter
| Company: | 3M ESPE AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent: | Dr. Desi W. Soegiarto,Regulatory Affairs Specialist |
| Phone: | 011-49-8152-700 1169 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | desi.soegiarto@mmm.com |
| Date: | March 11, 2010 |
Name of Device
| Proprietary Name: | Unicem Aplicap/Maxicap |
|---|---|
| Classification Name: | Dental cement other than zinc oxide- eugenol |
| Common Name: | Self adhesive cement |
Predicate Devices
Panavia F 2.0 by Kuraray Medical Inc., Japan .......................K032455 Maxcem 2 by Kerr Corporation, U.S.A.................................(K073209) (presumably marketed as Maxcem Elite)
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Description for the Premarket Notification
Unicem Aplicap/Maxicap is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275 [b]) because it is a device composed of various materials other than zinc oxide-eugenol.
Unicem Aplicap/Maxicap cements are dual-curing, self-adhesive resin cements available in two single dose delivery systems in capsules (K020256). They are used for the permanent cementation of indirect restorations made of ceramic, composite, or metal, and for posts and screws. Bonding and conditioning of the prepared tooth structure are not necessary with Unicem Aplicap™ and Maxicap™M.
Unicem Aplicap™ and Unicem Maxicap™ release fluoride ions, and are available in various shades. Unicem Aplicap™ and Unicem Maxicap™ contain bifunctional (meth)acrylate.
Unicem Aplicap™ and Unicem Maxicap™ have been cleared under K020256. This 510(k) Premarket Notification has been submitted in order to seek for clearance for new Indications for Use:
Final cementation of 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges
(excluded for patients with bruxism or periodontitis)
Final cementation of ceramic, composite or metal restorations on implant abutments & Cementation of abutments made of Lava™ zirconium oxide ceramic
Predicate devices to which Unicem Aplicap™ and Maxicap™ have been compared are Panavia F 2.0 by Kuraray Medical Inc., Japan (K032455) and Maxcem Elite by Kerr Corporation, U.S.A (K073209). Like its predicate devices Unicem Aplicap™ and Maxicap™ are dual-curing resin based cement system containing methacrylate. Like Panavia F 2.0, Unicem Aplicap™ and Maxicap™ release Fluoride.
The comparison for performance data and indications for use shows that Unicem Aplicap™ /Maxicap™ is substantially equivalent to its predicate devices Panavia F 2.0 by Kuraray Medical Inc., Japan (K032455) and Maxcem Elite by Kerr Corporation, U.S.A (K073209).
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To provide evidence for safety biocompatibility testing was carried out. The results show that Unicem Aplicap™ / Maxicap™ is a safe device.
In summary, it can be concluded that safety and effectiveness requirements for Unicem are completely met.
Indications for Use:
Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis)
Final cementation of post and screws
Final cementation of ceramic, composite or metal restorations on implant abutments Cementation of abutments made of Lava™ zirconium oxide ceramic
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Dr. Desi W. Soegiarto Regulatory Affairs Specialist 3M ESPE AG Dental Products ESPE Platz D-82229 Seefeld GERMANY
APR - 8 2010
Re: K094007
Trade/Device Name: Unicem Aplicap/Maxicap Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA Dated: March 23, 2010 -Received: March 25, 2010
Dear Dr. Soegiarto:
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 - Dr. Soegiarto
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 Parl 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Nh foc
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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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
Unicem Aplicap/Maxicap
Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis) Final cementation of post and screws Final cementation of ceramic, composite or metal restorations on implant abutments Cementation of abutments made of Lava™ zirconium oxide ceramic
Prescription Use
(Part 21 CFR 801 Subpart D)
✓
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ASBetz DDS for Dr. K.P. Mulkey
(Division Sign-Off)
(Division Sign-Off) Division of Anesthesiology, General Hosp Infection Control, Dental Device
Page 1 of
510(k) Number: K0940017
§ 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.