(82 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a dental cement, with no mention of AI or ML.
No.
The device is a resin cement used for final cementation of dental restorations, which is a supportive function rather than treating or curing a disease or condition.
No
The device is described as a resin cement used for the final cementation of various dental restorations. Its purpose is to physically bond materials, not to diagnose medical conditions or diseases.
No
The device description clearly indicates it is a physical resin cement material in a dispenser, not a software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dental cement for the final cementation of various dental restorations (inlays, onlays, crowns, bridges, posts, screws, restorations on implant abutments, and abutments). This is a therapeutic and restorative application, not a diagnostic one.
- Device Description: The description details the composition and properties of a dental cement, not a reagent, instrument, or system intended for use in the in vitro examination of specimens derived from the human body.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the cement (film thickness, working time, setting time, strength, hardness, radiopacity), which are relevant to its function as a dental adhesive, not its ability to diagnose a condition.
- Key Metrics: The key metrics presented are measurements of the cement's physical characteristics, not diagnostic performance metrics like sensitivity, specificity, PPV, or NPV.
In vitro diagnostics are used to examine specimens from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function.
N/A
Intended Use / Indications for Use
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 LavaTM zirconium oxide ceramic.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
Unicem HM in the ClickerTM dispenser is a dual-curing, self-adhesive resin cement for hand mixing. It contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 70% by weight; the grain size (D 90%) is about 12.5 um. The mixing ratio; based on volume, is 1 part base paste : 1 part catalyst. The cement is available in various shades.
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)
The following table shows the performance data of Unicem HM and its predicate device Unicem Aplicap:
| | Method | Limit | Unicem
HM | Unicem
Aplicap |
|---|---|---|---|---|
| Film thickness [micro meter] | ISO 4049 | 60 | pass | pass |
| Setting time [min:s] | ISO 4049 | 1.0 | 2.3 | 2.4 |
| Flexural strength [MPa] | dark cured ISO 4049 | > 50 | 57 +/- 11 | 53 +/- 7 |
| Flexural strength [MPa] | light cured ISO 4049 | > 50 | 87 +/- 9 | 64 +/- 6 |
| Compressive strength [MPa] | dark cured ISO 9917 | > 70 | 247 +/- 16 | 209 +/- 15 |
| Compressive strength [MPa] | light cured ISO 9917 | > 70 | 281 +/- 15 | 218 +/- 13 |
| Surface hardness [MPa] | dark cured DIN 2039-1 | n.a. | 202 +/- 8 | 209 +/- 13 |
| Surface hardness [MPa] | light cured DIN 2039-1 | n.a. | 280 +/- 35 | 151 +/- 10 |
Biocompatibility testing was carried out.
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.
K094007, K020256, K032455, K073209
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.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JUN 2 2 2010
Submitter
)
g
| 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: | June 09, 2010 |
Name of Device
| Proprietary Name: | Unicem HM |
|---|---|
| Classification Name: | Dental cement other than zinc oxide- eugenol |
| Common Name: | Self adhesive cement |
Predicate Devices
Unicem Aplicap/Maxicap by 3M ESPE AG, Germany.........K094007, K020256 Panavia F 2.0 by Kuraray Medical Inc., Japan ................................................................................................................................. Maxcem 2 by Kerr Corporation, U.S.A., presumably marketed as Maxcem Elite ..........................................................................................................................................
1
Description for the Premarket Notification
i
Unicem HM 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 oxideeugenol.
Unicem HM in the Clicker™ dispenser is a dual-curing, self-adhesive resin cement for hand mixing. It contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 70% by weight; the grain size (D 90%) is about 12.5 um. The mixing ratio; based on volume, is 1 part base paste : 1 part catalyst. The cement is available in various shades.
Unicem HM has been cleared under K062292. This 510(k) Premarket Notification has been submitted in order to seek clearance for additional new Indications for Use listed hereafter:
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.
The predicate devices to which Unicem HM has been compared are Unicem Aplicap/Maxicap by 3M ESPE AG, Germany (K094007, K020256), Panavia F 2.0 by Kuraray Medical Inc., Japan (K032455) and Maxcem 2 by Kerr Corporation, U.S.A., presumably marketed as Maxcem Elite (K073209).
As its predicate devices, Unicem HM is a dual-curing (chemical and light) resin based cement system containing methacrylate to be used with metal, composite, and porcelain restorations. Maxcem Elite and Unicem HM are both paste/paste systems.
The intended use of Unicem HM is comparable to the area of the intended use of the predicate devices of Unicem HM.
In this 510(k) premarket notification Unicem HM has been compared to its predicate devices with regard to chemical composition, performance data and indications for use. The comparison for chemistry, performance data and indications for use shows that Unicem HM is substantially equivalent to the predicate devices: Unicem Aplicap/Maxicap by 3M ESPE AG, Germany (K094007, K020256), Panavia F 2.0 by
2
Kuraray Medical Inc., Japan (K032455) and Maxcem 2 by Kerr Corporation, U.S.A., presumably marketed as Maxcem Elite (K073209).
The following table shows the performance data of Unicem HM and its predicate device Unicem Aplicap:
| | Method | Limit | Unicem
HM | Unicem
Aplicap |
|----------------------------|------------------------|-------|--------------|-------------------|
| Film thickness [µm] | ISO 4049 | 60 | pass | pass |
| Setting time [min:s] | ISO 4049 | 1.0 | 2.3 | 2.4 |
| Flexural strength [MPa] | dark cured ISO 4049 | > 50 | $57 \pm 11$ | $53 \pm 7$ |
| Flexural strength [MPa] | light cured ISO 4049 | > 50 | $87 \pm 9$ | $64 \pm 6$ |
| Compressive strength [MPa] | dark cured ISO 9917 | > 70 | $247 \pm 16$ | $209 \pm 15$ |
| Compressive strength [MPa] | light cured ISO 9917 | > 70 | $281 \pm 15$ | $218 \pm 13$ |
| Surface hardness [MPa] | dark cured DIN 2039-1 | n.a. | $202 \pm 8$ | $209 \pm 13$ |
| Surface hardness [MPa] | light cured DIN 2039-1 | n.a. | $280 \pm 35$ | $151 \pm 10$ |
Biocompatibility testing was carried out.
ﺮﺓ ﻣﺴﺘ
In summary, it can be concluded that Unicem HM is a safe and effective as as the predicate devices: Unicem Aplicap/Maxicap by 3M ESPE AG, Germany (K094007, K020256), Panavia F 2.0 by Kuraray Medical Inc., Japan (K032455) and Maxcem 2 by Kerr Corporation, U.S.A., presumably marketed as Maxcem Elite (K073209).
3
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.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized emblem consisting of three curved shapes, possibly representing human figures or abstract forms. The emblem is black, and the text is also in black.
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 Seefeld, Bavaria Germany D-82229
JUN 2 2 2010
Re: K100908
Trade/Device Name: Unicem HM Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 29, 2010 Received: April 1, 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.
5
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 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 vours.
Susan Gunnes
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
6
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
Unicem HM
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
X Prescription Use (Part 21 CFR 801 Subpart Di
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)
Kein Muluy for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of _
510(k) Number: K100908