M.L. PRIMER

K040079 · Shofu Dental Corp. · KLE · Sep 9, 2004 · Dental

Device Facts

• Record ID: K040079
• Device Name: M.L. PRIMER
• Applicant: Shofu Dental Corp.
• Product Code: KLE · Dental
• Decision Date: Sep 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

M.L. Primer is a metal-adhesive primer to promote adhesion between dental metal and resin-based materials intra- or extra-orally. M.L. Primer is intended for use for the following: - Used when fabricating and repairing resin facing crowns. - Used when fabricating and repairing crowns. - Used when repairing porcelain fused to facing crown. - Used when fabricating and repairing denture base with metal plate, metal clasp or metal attachments. - Used for bonding metal restorations (inlays, onlays, crowns and bridges), metal splints, metal posts and cores using adhesive resin cement or used for their repair.

Device Story

M.L. Primer is a chemical bonding agent applied to dental metal surfaces to facilitate adhesion with resin-based restorative materials. Used by dental professionals in clinical or laboratory settings; applied intra- or extra-orally during fabrication or repair of metal-based dental prosthetics (crowns, bridges, inlays, onlays, splints, posts, cores, denture bases). The primer modifies the metal surface to improve chemical compatibility with resin cements or facing materials, enhancing the structural integrity of the final restoration. No complex instrumentation or electronic processing is involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Chemical bonding agent for dental metal-to-resin adhesion. Liquid formulation. No electronic components, software, or energy sources. Sterilization not applicable as it is a chemical primer.

Indications for Use

Indicated for dental professionals to promote adhesion between dental metal and resin-based materials during fabrication or repair of crowns, bridges, inlays, onlays, splints, posts, cores, and denture bases.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2004

Mr. David P. Morais Operations Manager Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92069

Re: K040079

Trade/Device Name: M.L. Primer Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 3, 2004 Received: September 7, 2004

Dear Mr. Morais:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1) 1) vice 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 - Mr. Mr. Mr. Morais

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DTS issualles or abat your device complies with other requirements Incall that I DA nas made a actessions regulations administered by other Federal agencies. of the Act of ally I ederal statutes and regarments, including, but not limited to: registration You must comply with an are riseeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), lasting (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality ion 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 anon you to ought time of substantial equivalence of your device to a premarket nothleadon. The First matts 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 specific advice for your de 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 general meetirs, International and Consumer Assistance at its toll-free Dryison [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

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

510(k) Number (if known): K040079

Device Name: M.L. Primer

Indications For Use:

M.L. Primer is a metal-adhesive primer to promote adhesion between dental metal and
esses of the supportunes and to are are are are are liv M.C. Phiner 13 a moter a intra- or extra-orally.

M.L. Primer is intended for use for the following:

- Used when fabricating and repairing resin facing crowns. .
- Used when rabneating and repairing and repairing crowns. .
- Used when repairing porcelain rased to faung crown.
Used when fabricating and repairing denture base with metal plate, metal clasp . or metal attachments.
- or metal attachments.
Used for bonding metal restorations (inlays, onlays, crowns and bridges), metal
e super of bonding metal restorations (indecive resin coment or . Used for bonding metal restorations (imays) cadhesive resin cement or splints, metal poolo on hand used for their repair.

Susan Rinn

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K042771

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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)

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