(79 days)
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.
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.
The provided text doesn't contain information about acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical or performance study with quantitative metrics. The document is a 510(k) summary for a dental resin, focusing on establishing substantial equivalence to a predicate device.
Here's an analysis of why the requested information isn't available in the text and what is provided:
Missing Information (and why):
- 1. A table of acceptance criteria and the reported device performance: This type of performance data (e.g., accuracy, sensitivity, specificity, specific physical properties with thresholds) is not presented. The submission relies on establishing similarity to a predicate device.
- 2. Sample size used for the test set and the data provenance: No specific test set data is mentioned.
- 3. Number of experts used to establish the ground truth... and their qualifications: No expert review process for a test set is described.
- 4. Adjudication method: Not applicable as there's no expert review.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No such study is mentioned.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a dental material, not an algorithm.
- 7. The type of ground truth used: Not applicable in the context of device performance testing.
- 8. The sample size for the training set: Not applicable for a physical medical device.
- 9. How the ground truth for the training set was established: Not applicable for a physical medical device.
What the document does provide concerning "proving" the device:
The "proof" in this 510(k) submission comes from establishing substantial equivalence to an already legally marketed predicate device (K831647 Dentsply).
The key statements supporting this are:
- "The Bredent product is similar 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."
- "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." (However, the details of this data are not provided in this summary.)
- "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 raise any kind of question regarding safety and effectiveness of the finished product."
Essentially, the acceptance criteria are based on meeting the established safety and effectiveness profile of the predicate device, demonstrated through a comparison of technical characteristics and existing market experience. No specific performance study with defined quantitative acceptance criteria is detailed in this 510(k) summary.
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>>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: info@bredent.com
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: denk@denkgruppe.de
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 (800) 638-2041 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
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Ruper
Carnal Hopp
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§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
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.(b)
Classification. Class II.