PULPDENT VLC RESIN CEMENT

K040236 · Pulpdent Corporation · EMA · Apr 20, 2004 · Dental

Device Facts

• Record ID: K040236
• Device Name: PULPDENT VLC RESIN CEMENT
• Applicant: Pulpdent Corporation
• Product Code: EMA · Dental
• Decision Date: Apr 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pulpdent VLC Resin Cement is a fluoride-releasing, visible light-cure dental resin cement that contains no Bisphenol A. It is used to permanently cement ceramic restorations, such as Cerec, porcelain crowns, inlays, onlays, bridges, veneers, and periodontal splints to tooth structure.

Device Story

Pulpdent VLC Resin Cement is a fluoride-releasing, visible light-cure dental resin cement; formulated without Bisphenol A. Used by dental professionals in clinical settings to permanently bond ceramic restorations—including crowns, inlays, onlays, bridges, veneers—and periodontal splints to natural tooth structure. The material is applied to the restoration and tooth interface, then cured using a visible light source. The cement provides a stable, permanent fixation for dental prosthetics, benefiting patients by restoring function and aesthetics to damaged or missing teeth.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, composition, and performance characteristics compared to legally marketed predicate devices.

Technological Characteristics

Fluoride-releasing, visible light-cure dental resin cement. Bisphenol A-free formulation. Class II dental cement per 21 CFR 872.3275.

Indications for Use

Indicated for permanent cementation of ceramic restorations (crowns, inlays, onlays, bridges, veneers) and periodontal splints to tooth structure in dental patients.

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.

Predicate Devices

• Pulpdent Post Cement
• Pulpdent ResiLute
• Kuraray / J. Morita Panavia F
• ESPE Compolute Aplicap
• Ivoclar / Vivadent Variolink II

Submission Summary (Full Text)

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# Ko40236

## APR 2 0 2004

#### EXHIBIT 2

### SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA

617-926-6666 Telephone: [phone] Fax: [e-mail]

DEVICE: Trade Name: PULPDENT VLC RESIN CEMENT Classification Name: Dental Cement FDA Product Code: 76 EMA, 21 CFR Part 872.3275

#### PREDICATE DEVICE:

Pulpdent Post Cement Pulpdent ResiLute Kuraray / J. Morita Panavia F ESPE Compolute Aplicap lvoclar / Vivadent Variolink II

#### DESCRIPTION AND INTENDED USE:

PULPDENT VLC Resin Cement is a fluoride-releasing, visible light cure dental resin cement that contains no Bisphenol A. It is used to permanently cement ceramic restorations, such as Cerec, porcelain crowns, inlays, onlays, bridges, veneers and periodontal splints to tooth structure.

#### COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT VLC Resin Cement is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.

#### SAFETY AND EFFECTIVENESS:

PULPDENT VLC Resin Cement is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above. The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR 872.3275.

According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit-torisk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of shortterm or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 0 2004

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472

Re: K040236

Trade/Device Name: Pulpdent VLC Resin Cement Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 28, 2004 Received: February 2, 2004

Dear Mr. Berk:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have rother of a now and have determined the device is substantially equivalent (for the icitications 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to active 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 upprovisions of the Act. The general controls provisions of the Act include controls providents of the sixtation, 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 If your device to such additional controls. Existing major regulations affecting (1 Mrs), it may of subject to back of federal Regulations, Title 21, Parts 800 to 898. In your device ear be fourther announcements concerning your device in the Federal Register.

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Page 2 - Mr Berk

Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe advisou mat 1 DTC Isbance or abat your device complies with other requirements mean that FDA has made a detes and regulations administered by other Federal agencies. of the Act of ally I ederal states and regirements, including, but not limited to: registration 1 ou must comply with an alle Hotel Stag (21 CFR Part 801); good manufacturing practice alla listing (21 CF R Part 807), abality systems (QS) regulation (21 CFR Part 820); and if requirenchts as set form in the quarty ajon 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) This letter will anow yourse overnment of substantial equivalence of your device to a premaired 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), If you desire speomle at 100 to: Join we at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ken Mulvey

for Chiu Lin, Ph.D. 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

K040236 AND 200

510 (k) Number (if known)

PULPDENT VLC RESIN CEMENT Device Name

#### Indications for Use:

Pulpdent VLC Resin Coment is a fluoride releasing, visible light-cure dental resin rement that contains no Bisphenol A. It is used to permanently cement ceramic coment that contains no crowns, inlays, onlays, bridges, bridges, veneers, and periodontal splints to tooth structure.

Prescription Use __ (Part 21 CFR 801 Subpart D) ா

Over-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) (Division Sign-C (Division Sign-Off)
Division of Anesthesiology - . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Division of Anesthoolorsis Devices 444 510(k) Number: Page 1 of 1