(38 days)
K 972573
Not Found
No
The device description focuses on the material composition and fabrication process of a denture resin, with no mention of AI or ML technologies.
No.
The device is a material for fabricating dentures, which are prosthetic devices used to replace missing teeth, not to treat a disease or condition.
No
Explanation: The device description clearly states its intended use is for the "Fabrication of full and partial dentures" and it is classified as a "denture relining, repairing, or rebasing resin." There is no mention of it being used to diagnose medical conditions or diseases.
No
The device description clearly states it is a material composed of methylmethacrylate, which is a physical substance used in the fabrication of dentures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Fabrication of full and partial dentures." This is a manufacturing process for a medical device (dentures), not a diagnostic test performed on a biological sample.
- Device Description: The description clearly states it's a "denture relining, repairing, or rebasing resin" used in the "fabrication of complete or partial removable dentures and other removable dental appliances." This reinforces its role in creating a physical device for oral use.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Regulatory Classification: The classification is "denture relining, repairing, or rebasing resin (21 C.F.R. § 872.3760)," which falls under dental devices, not IVDs.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. This device does not fit that description.
N/A
Intended Use / Indications for Use
Fabrication of full and partial dentures
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
PALADON® 65 by Kulzer, PALAPRESS® VARIO by Kulzer, LIQCRYLIC® by Dentsply K 972573
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
2
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