(38 days)
Fabrication of full and partial dentures
VITRON® H is classified as a denture relining, repairing, or rebasing resin (21 C.F.R. § 872.3760) because it is a device composed of methylmethacrylate intended to be used in the fabrication of complete or partial removable dentures and other removable dental appliances. VITRON® H is a pourable, heat cured material for the production of dentures according to the plugging-pressing procedure of flask polymerization.
This document is a 510(k) summary for VITRON® H, a denture base material. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for the device itself. Therefore, many of the requested sections regarding device performance and ground truth cannot be fully provided from the given text.
Here is the information that can be extracted or inferred based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format. The core of the submission relies on the "substantial equivalence" of VITRON® H to already marketed predicate devices with a long clinical history. The performance is implied to be equivalent to these predicate devices.
| Metric / Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (VITRON® H) |
|---|---|---|
| Material composition | Similar monomer system to predicates | Uses common monomer system (methylmethacrylate) |
| Curing mechanism | Barbituric acid catalyzed system, similar to predicates | Uses barbituric acid catalyzed starting mechanism |
| Intended Use | Fabrication of complete or partial removable dentures and other removable dental appliances, same as predicates | Fabrication of full and partial dentures |
| Safety & Effectiveness | Comparable to predicates with long marketing history and clinical experience | Substantially equivalent to PALADON® 65, PALAPRESS® VARIO, and LIQCRYLIC® PRO DENTAL RESIN, all well-established as safe and effective. No biocompatibility studies deemed necessary due to long clinical history of similar technology. |
| Performance Data | Supports safety and effectiveness for intended use (presumably through physical and chemical property comparisons, though not detailed in this summary) | Performance data (not detailed in this summary) supports safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly detailed in the provided text. The submission focuses on demonstrating substantial equivalence to predicate devices with long marketing histories and clinical experience. This suggests the "test set" is more of a comparative analysis rather than a direct study on VITRON® H with a specific sample size. The provenance is inferred to be from general clinical history and market experience of the predicate devices.
- Sample Size for Test Set: Not specified.
- Data Provenance: The claim is based on the long marketing history and clinical experience of predicate devices (PALADON® 65, PALAPRESS® VARIO, LIQCRYLIC® PRO DENTAL RESIN). These predicates have been marketed in the United States since 1992 (PALAPRESS® VARIO) and in Europe/South America for over 25 years (SELECTA-PLUS® and TREVAPRESS®). This suggests historical and retrospective data from diverse regions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of submission. The ground truth for the safety and effectiveness of the predicate devices is established by their market longevity and clinical acceptance over many years. For VITRON® H, its substantial equivalence to these predicates negates the need for new expert ground truth establishment in this context.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a specific test set with human adjudication in this 510(k) summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a submission for a denture base material, not an AI or imaging device that would typically involve an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is not an software/AI device.
7. The Type of Ground Truth Used
The "ground truth" for the safety and effectiveness of VITRON® H is indirectly established through the long-term clinical history, market acceptance, and established safety and effectiveness of its predicate devices. The document states that the technology (methyl methacrylate based denture base materials cured by a barbituric acid based catalyst system) is over 30 years old and has a long clinical history.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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MAY 20 199
II. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
| Name: | ESPE Dental AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Contact: | Dr. Andreas Petermann, Regulatory Affairs |
| Phone: | 011-49-8152-7001395 |
| Fax: | 011-49-8152-7001869 |
| Andreas_Petermann @ESPE.de | |
| Date: | April 9, 1999 |
Name of Device
| Proprietary Name: | VITRON ® H |
|---|---|
| Classification Name: | Denture relining, repairing, or rebasing resin |
| Common Name: | Denture base material |
Predicate Devices
| PALADON® 65 by Kulzer | |
|---|---|
| PALAPRESS® VARIO by Kulzer | |
| LIQCRYLIC® by Dentsply K 972573 |
Description for the Premarket Notification
VITRON® H is classified as a denture relining, repairing, or rebasing resin (21 C.F.R. § 872.3760) because it is a device composed of methylmethacrylate intended to be used in the fabrication of complete or partial removable dentures and other removable dental appliances.
VITRON® H is a pourable, heat cured material for the production of dentures according to the plugging-pressing procedure of flask polymerization. It is thus similar and substantially equivalent in intended use and function to Kulzer's denture relining, repairing, or rebasing resin PALADON® 65 (K 901789).
Image /page/0/Picture/12 description: The image shows the text "510(k) VITRON® H" above the word "ESPE". To the left of the word ESPE is a logo of a tree inside of a square. The text and logo are all in black and white.
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Though the composition of PALADON® 65 is not available it is known that it consists of the same common monomer system. Kulzer's PALAPRESS® VARIO and Dentsply's LIQCRYLIC® PRO DENTAL RESIN do also comprise similar monomers and use the same well-known barbituric acid catalyzed starting mechanism as Vitron® H.
Kulzer's PALADON® 65. PALAPRESS® VARIO and Dentsply's LIQCRYLIC® PRO DENTAL RESIN are well established and determined to be safe and effective devices.
PALAPRESS® VARIO is marketed in the United States since 1992. Dentsply has marketed the same device as SELECTA-PLUS® and TREVAPRESS® in Europe and South America for over 25 years. The technology of methyl methacrylate based denture base materials which are cured by a barbituric acid based catalyst system is over 30 years old and has a long clinical history. In our opinion biocompatibility studies are therefore not necessary to prove the safety and efficacy of VITRON® H's formulation.
In our opinion the substantial equivalence of VITRON® H to the predicate devices PALADON® 65, PALAPRESS® VARIO and LIQCRYLIC® PRO DENTAL RESIN with long marketing history and clinical experience, and the performance data support the safety and effectiveness of VITRON® H for the intended use.
Image /page/1/Picture/4 description: The image shows the text "510(k) VITRON H" on the top line. Below that is a logo of a leaf inside of a square. To the right of the logo is the text "ESPE" in large, bold letters. The image appears to be a product label or logo.
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.
MAY 20 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Andreas Petermann Regulatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld Bavaria, Germany
Re : K991220 Trade Name: Vitron®H Requlatory Class: II Product Code: EBI Dated: April 9, 1999 Received: April 12, 1999
Dear Dr. Petermann:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Petermann
this response to your premarket notification Please note: submission does not affect any obligation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597
or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
Device Name:
Vitron® H
Indications for use:
Fabrication of full and partial dentures
Prescription use: 网
Over-the counter use □
Susan Runnr
(Division Sign-C Division of Dental, Int and General Hospital 510(k) Number
§ 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.