PALAIMPACT

K043504 · Heraeus Kulzer, Inc. · EBI · Jan 28, 2005 · Dental

Device Facts

• Record ID: K043504
• Device Name: PALAIMPACT
• Applicant: Heraeus Kulzer, Inc.
• Product Code: EBI · Dental
• Decision Date: Jan 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PalaImpact is a heat curing, high-impact denture acrylic resin for the fabrication of full and partial dentures. It is also used for fixed and removable prosthetics devices.

Device Story

PalaImpact is a heat-curing, high-impact denture acrylic resin used by dental professionals in laboratory settings. The material is processed via heat curing to fabricate full and partial dentures, as well as fixed and removable prosthetic devices. It serves as a restorative material to replace missing teeth and oral structures, improving patient function and aesthetics. The device is a material-based dental resin; it does not involve electronic inputs, software, or automated algorithms.

Clinical Evidence

Bench testing only.

Technological Characteristics

Heat-curing, high-impact denture acrylic resin. Class II device under 21 CFR 872.3760. Material properties are consistent with standard dental acrylic resins used for denture fabrication and repair.

Indications for Use

Indicated for the fabrication of full and partial dentures, as well as fixed and removable prosthetic devices in patients requiring dental restoration.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

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 and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2005

Ms. Cheryl V. Zimmerman Director, Quality Operations and Compliance Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614

Re: K043504

Trade/Device Name: Palaimpact® Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: December 15, 2004 Received: December 30, 2004

Dear Ms. Zimmerman:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication we have reviewed your Section 910(x) premained is substantially equivalent (for the ndications for as assemares referenced above and nave accemined the as not is eate devices marketed in interstate commerce use stated in the enclosure) to legally manical Device Amendments, or to devices that proof to May 28, 1970, the chaomism and 61 the Federal Food, Drug, and Cosmetic have been reclassified in accordance with the provise approval application (PMA). The garges therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, subject to the general secure and registration, list in the register on confors provisions of the netude requibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) this enames regulations affecting your device can be may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of I caeries in the Federal Register.

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## Page 2 – Ms. Cheryl V. Zimmerman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's Issualice of a substinate equires with other requirements of the Act or that FDA has made a determination that your accuration of the Federal associes. You must comply with
any Federal statutes and regulations administered by other Federal on CE any Federal statutes and regulations administered by ther restration and listing (21 CFR Part 807),
all the Act's requirements, including, but not limited to: registration th all the Act's requirements, including put not innited to: requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as see labeling (21 CFR Part 801); good manufacturing production the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applied 100 100 systems (QS) regulation (21 CF 1-542 of the Act); 21 CFR 1000-1050.
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 allow you to oegill makemig your article equivalence of your device to a legally premarket notification. The PDA midnig of sacomman or 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), please
rs of the many of the 10, 2019 11: All any alsos note the requiried If you desire specific advice for your de not our s. Also, please note the regulation entitled, a contact the Utfice of Compilance at (240) 210 of 1979. You may obtain other
"Misbranding by reference to premarket notification" (21 CFR Part Birgion of Small "Misbranding by reference to premailities under the Act from the Division of Small general information on your responsibilities and at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toldsmanain html Manufacturers, International and Consultive Noww.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chris S. Liem, Ph.D.

Chiu S. Lin, PhD 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

1104 3504 510(k) Number (if known):

Palaimpact Device Name:

Indications for Use: PalaImpact is a heat curing, high-impact denture acrylic resin for Thatications for USC. Transpact to a new casing, again is also used for fixed and removable prosthetics devices.

Prescription Use V AND/OR (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)

Susan Bunner

KO43504

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

510(k) Number _

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