PROTEC CEM.

K980922 · Ivoclar North America, Inc. · EMA · Apr 30, 1998 · Dental

Device Facts

• Record ID: K980922
• Device Name: PROTEC CEM.
• Applicant: Ivoclar North America, Inc.
• Product Code: EMA · Dental
• Decision Date: Apr 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Protec Cem is intended to be used with crowns and bridges constructed of Targis/Vectris material on conventionally prepared stumps with adequate mechanical retention. Cementation of metal or Porcelain Fused to Metal (PFM) inlays, partial crowns, crowns, bridges, as well as metal root canal posts, metal post build ups, and orthodontic bands.

Device Story

Protec Cem is a dental cement used by dentists for the permanent fixation of various dental restorations. It is applied to crowns, bridges, inlays, partial crowns, metal root canal posts, metal post build-ups, and orthodontic bands. The device is used in a clinical setting by dental professionals. It functions as a bonding agent to secure restorations to prepared tooth stumps that possess adequate mechanical retention. The cement provides the necessary adhesion to ensure the stability and longevity of the dental prosthetic or appliance within the patient's mouth.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental cement for restorative applications. Materials and specific chemical composition not detailed in the provided text. Intended for use on prepared stumps with mechanical retention.

Indications for Use

Indicated for cementation of dental restorations including crowns, bridges, inlays, and partial crowns made of Targis/Vectris, metal, or PFM; also indicated for metal root canal posts, metal post build-ups, and orthodontic bands on prepared stumps with mechanical retention.

Regulatory Classification

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. 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1998

Mr. Peter P. Mancuso ·Requlatory/Quality Assurance Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228

Re : K980922 Trade Name: Protec Cem. Requlatory Class: II Product Code: EMA Dated: March 9, 1998 Received: March 11, 1998

Dear Mr. Mancuso:

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, Druq, 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. A substantially equivalent determination assumes compliance with ma the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Mancuso

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 diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact
the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

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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Page 1 of 1

| 510(k) Number (if known): | Not Known K980922 |
|---------------------------|-------------------|
| Device Name: | Protec Cem |

Indications For Use:

Intended Use: Protec Cem is intended to be used with crowns and bridges constructed of Targis/Vectris material on conventionally prepared stumps with adequate mechanical retention. Cementation of metal or Porcelain Fused to Metal (PFM) inlays, partial crowns, crowns, bridges, as well as metal root canal posts, metal post build ups, and orthodontic bands.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Swoon Purves*

(Division Sign-Off) Division of Donui. Infection Control, and General Inspitat 510(k) Number

Prescription Use (Per 21 CFR 801.109)

・・・

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)