K Number
K973961
Device Name
3M DENT SYSTEM II PLUS
Manufacturer
Date Cleared
1997-12-17

(62 days)

Product Code
Regulation Number
872.3275
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is indicated for direct dental bonding applications.
Device Description
3M™ Dent System II Plus is a two part, radiopaque dual-curing luting composite. This device, as well as the predicate devices, are based on methacrylate resin chemistry. The 3M™ Dent System II Plus Paste A alone can be cured by exposure to a dental visible light curing unit. When Pastes A and B are mixed, the material will chemically cure without exposure to light or can be cured by exposure to visible light.
More Information

Not Found

Not Found

No
The summary describes a dental bonding material based on methacrylate resin chemistry and its curing properties. There is no mention of AI, ML, image processing, or any computational analysis of data.

No

Explanation: The device is a dental luting composite used for bonding, which is a restorative rather than therapeutic application.

No
The device is a luting composite used for direct dental bonding applications, not for diagnosing conditions.

No

The device description clearly states it is a "two part, radiopaque dual-curing luting composite," which 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 is for "direct dental bonding applications." This is a therapeutic or restorative application, not a diagnostic one.
  • Device Description: The description details a "luting composite" used for bonding, which is consistent with dental restorative procedures.
  • Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is to bond dental materials, which is a direct treatment or restoration.

N/A

Intended Use / Indications for Use

This device is indicated for direct dental bonding applications.

Product codes

EMA

Device Description

3M™ Dent System II Plus is a two part, radiopaque dual-curing luting composite. This device, as well as the predicate devices, are based on methacrylate resin chemistry. The 3M™ Dent System II Plus Paste A alone can be cured by exposure to a dental visible light curing unit. When Pastes A and B are mixed, the material will chemically cure without exposure to light or can be cured by exposure to visible light.

3M™ Dent System II Plus is used in conjunction with a dental adhesive system to bond direct and indirect restorations. The predicate devices, when taken as a whole have the same intended uses.

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)

Based on the conclusions drawn from the safety analysis conducted for this device and the results of the bench testing, 3M™ Dent System II Plus is safe, effective and performs as well or better than the predicate devices mentioned above.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

3M™ Scotchbond™ Resin Cement, Bisco Resinomer™, Bisco Duolink™

Reference Device(s)

Not Found

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

Ka73961/

DEC 17 1997

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Name:Lael J. Pickett
Regulatory Affairs Specialist
Address:3M Dental Products Laboratory
3M Center, Building 260-2B-12
St. Paul, MN 55144-1000
Telephone:612-733-3594
Fax:612-736-0990
Trade Name:3M™ Dent System II Plus
Common Names:Resin cement, luting composite, luting cement
Classification Name:Dental cement, other than zinc oxide-eugenol
(21 CFR §872.3275)
Predicate Devices:3M™ Scotchbond™ Resin Cement
Bisco Resinomer™
Bisco Duolink™

3M™ Dent System II Plus is a two part, radiopaque dual-curing luting composite. This device, as well as the predicate devices, are based on methacrylate resin chemistry. The 3M™ Dent System II Plus Paste A alone can be cured by exposure to a dental visible light curing unit. When Pastes A and B are mixed, the material will chemically cure without exposure to light or can be cured by exposure to visible light.

3M™ Dent System II Plus is used in conjunction with a dental adhesive system to bond direct and indirect restorations. The predicate devices, when taken as a whole have the same intended uses.

3M™ Dent System II Plus and predicate devices have similar technological characteristics as indicated by their methacrylate resin chemistry. This is further validated by the comparative results of the bench tests conducted. These tests include shear bond strength, compressive and diametral tensile strengths, and film thickness.

Based on the conclusions drawn from the safety analysis conducted for this device and the results of the bench testing, 3M™ Dent System II Plus is safe, effective and performs as well or better than the predicate devices mentioned above.

1

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

. . . . .

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lael J. Pickett Requlatory Affairs Specialist 3M Dental Company 3M Dental Products Laboratory 3M Center, Building 260-2B-12 St. Paul, Minnesota 55144

DEC 17 1997

Re : K973961 Trade Name: 3M™ Dent System II Plus Requlatory Class: II Product Code: EMA Dated: October 14, 1997 Received: October 16, 1997

Dear Ms. Pickett:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

2

Page 2 - Ms. Pickett

not affect any obligation you might have under sections 531
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):K973961
------------------------------------

1

Device Name:_3M™Dent System II Plus ______________________________________________________________________________________________________________________________________________________________________________

Indications For Use: This device is indicated for direct dental bonding applications.

(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 Dental, Infection Control, and General Hospital Devices
Prescription Use
(Per 21 CFR 801.109)Yes
OR
Over-The-Counter Use No

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