DENTAPLAST HOT, MODEL 16-XXX

K052780 · Bredent-Products For the Dental Technician Laborat · EBI · Dec 21, 2005 · Dental

Device Facts

• Record ID: K052780
• Device Name: DENTAPLAST HOT, MODEL 16-XXX
• Applicant: Bredent-Products For the Dental Technician Laborat
• Product Code: EBI · Dental
• Decision Date: Dec 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The bredent denture relining, repairing or rebasing resin is intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base.

Device Story

Dentaplast is a methylmethacrylate-based polymerizing resin used in dental laboratories. It functions as a material for denture relining, repair of cracks/fractures, and fabrication of full or CoCr denture bases. The resin is formulated to be cadmium-free and uses a tertiary amine-free catalyst to enhance color stability and flowability. It is intended for use by dental technicians in a laboratory setting. The material is processed via a casting technique. By providing a stable, flowable resin, it allows for precise shaping of functional margins and structural restoration of dentures, ultimately benefiting patients by restoring denture fit, function, and integrity.

Clinical Evidence

No clinical data. Substantial equivalence is based on technical characteristics, material properties, and historical market performance in Europe without reported device failures.

Technological Characteristics

Methylmethacrylate-based polymerizing resin; cadmium-free; tertiary amine-free catalyst. Designed for use with resin casting systems. Formulated for extended processing time and flowability.

Indications for Use

Indicated for patients requiring denture relining, repair of fractured dentures, or fabrication of new denture bases.

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.

Predicate Devices

• Dentsply (K831647)

Submission Summary (Full Text)

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K052780

# >>Summary of Safety & Effectiveness

### 510(k) Summary as required by section 807.92(c)

Date: 03 16/05

Suomission Applicant: Bredent - Products for the dental technician laboratory Weissennornerstr. 2 89250 Serden

Phone: xx49-7309-872-230 Fax: xx49-7309-872-24 E-mail: [e-mail]

Establishment Registration Number: 1000303432

Application corresondent/Contact person: think - healthcare management Schwarzwaldstr. 11 D-78532 Tuttlingen/Germany

Phone: xx49-7462-91300 Fox: xx49-7462-91301 E-mail: [e-mail]

Trade name: Bredent - Dentaplast

Common name: Denture Relining, Repair/Rebasing resin

Classfication name: Denture Relining, Repair/Rebasing resin, Dental (21 CFR 872.3760 - EBI)

Substantial Equivalence Claim: K831647 - Dentsply -

#### Description of the Device:

Dentaplast hot is a polymerizing denture resin on the basis of methylmetacrylate. Dentaplast hot allows to obtain extended processing time and offers fine flowability and is therefore matched with the Dentaplast hot casting sstem. The catalyst is free from tertiary amine and ensures high colour stability. Dentaplast is entirely cadmium-free.

Application range:

-Fabrication of full dentures in the resin casting technique

-Completion of CoCr dentures

-Relinings and shaping of functional margins

-any type of repair work such as cracks, fractures.

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# »Summary of Safety & Effectiveness

#### Indications for Use:

The bredent denture relining, repairing or rebasing resin is intended to reline a denture surfacts tissue, to repair a fractured denture, or to form a new denture base

#### Comparison with P.D.

The Bredent product is similiar to the P.D. in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility characteristics as well as sizes and configurations. Therefore the Bredent product can be deemed substantially equivalent and effective for its indicated use.

#### Summary

The presented data that was conducted on the Bredent products shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any questions regarding safety and effectiveness. All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures. The used materials are well researched and do not roise any kind of question regarding safety and effectiveness of the finished product.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, symbolizing health, hope, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2005

Bredent C/O Mr. Markus Denk Think – Healthcare Management Schwarzwaldstr. 11 D-78532 Tuttlingen GERMANY

Re: K052780

Trade/Device Name: Dentaplast Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 09, 2005 Received: November 16, 2005

### Dear Mr. Denk:

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 your device 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. Markus Denk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualice of a substains complies with other requirement of the Act of that FDA nas made a decermination max your comments. You must complex. You must comply with any Federal Statules and regulations administred of to: registration and listing (21 CFR Part 817); all the Act s requirements, including, but novements as set forth in the quality labeling (21 CFR Part 001); good managaman (2017).
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation systems (QD) regalazed (=5) -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 you to begin maneting your antial equivalence of your device to a legally premarket notification: "The PDA midtle of backannel of backantal in a 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 If you desire specific advice for your ac not 2011-07-11 15. Also, please note the regulation entitled, a contact the Office of Comphance at (210) 270 03227 (21 CFR Part 807.97). You may obtain other "Misoralluming of Telected to promaibilities under the Act from the Division of Small general informational on your responsibilities assistance at its toll-free number [phone] or Manufacturers, International and Consulter r.its.com/cdrh/industry/support/index.html.

Sincerely yours,

Synette Y. Michie Dmd.

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

K052780

510(k) Number (if known):

Device Name: Dentaplast

Indications For Use:

The bredent denture relining, repairing or rebasing resin is intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use ______________ (21 CFR 801 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Super Ruper

Carnal Hopp

K052780

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