(78 days)
K 902115, K 972573
Not Found
No
The device description and intended use clearly define it as a material for fabricating and repairing dentures, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a denture base material used for fabrication, repair, or rebasing of dentures, which are restorative devices, not therapeutic. Its classification (21 C.F.R. § 872.3760) and intended use do not imply any therapeutic action.
No
The device description states that VITRON® M is a denture relining, repairing, or rebasing resin used in the fabrication, repair, and rebasing of dentures. It is a material used for treatment or fabrication, not for diagnosing a condition.
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 clearly states it's a denture base material for fabrication, repair, and rebasing of dentures. This is a material used in the mouth or on models of the mouth, not for testing samples in vitro (outside the body).
- Device Description: The description confirms it's a denture relining, repairing, or rebasing resin composed of methylmethacrylate. This is a material used in the physical construction and maintenance of dentures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health condition.
Therefore, VITRON® M is a dental material used for the physical construction and repair of dentures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Denture base material for: Completion of metal frameworks Partial and total denture rebasing Extension of partial dentures Repairs Fabrication of partial and total dentures
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
VITRON® M 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, repair, rebasing of complete or partial removable dentures and other removal dental appliances.
VITRON® M is a pourable, cold cured denture base material
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.
K 902115, 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
K990762
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS II.
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: | March 3, 1999 |
Name of Device
| Proprietary Name: | VITRON® M |
|---|---|
| Classification Name: | Denture relining, repairing, or rebasing resin |
| Common Name: | Denture base material |
Predicate Devices
| PALAPRESS® VARIO by Kulzer | K 902115 |
|---|---|
| LIQCRYLIC® by Dentsply | K 972573 |
Description for the Premarket Notification
VITRON® M 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, repair, rebasing of complete or partial removable dentures and other removal dental appliances.
VITRON® M is a pourable, cold cured denture base material and, thus similar and substantially equivalent in intended use and function to Kulzer's denture relining, repairing, or rebasing resin PALAPRESS® VARIO (K 902115) and Dentsply's LIQCRYLIC® PRO DENTAL RESIN (K 972573). Though the exact composition of PALAPRESS® VARIO and LIQCRYLIC® is not available, it is known that they consist of
Image /page/0/Picture/12 description: The image shows the text "510(k) VITRON® M ESPE". The text is arranged in three lines, with "510(k) VITRON® M" on the top line and "ESPE" on the bottom line. There is a logo to the left of the text.
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the same monomers and prepolymerized oligomers and are cured by the same well-known barbituric acid based initiator system as VITRON® M.
Kulzer's denture base material PALAPRESS® VARIO and Dentsply's LIQCRYLIC® PRO DENTAL RESIN are well established and determined to be safe and effective.
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® M's formulation.
In our opinion the substantial equivalence of VITRON® M to the predicate devices PALAPRESS® VARIO and LIQCRYLIC® with long marketing history and clinical experience, and the performance data support the safety and effectiveness of VITRON® M for the intended use.
Image /page/1/Picture/4 description: The image shows the text "510(k) VITRON M" on the top line. Below that is a logo of a tree inside of a square. To the right of the logo is the word "ESPE" in large, bold letters. The image is in black and white.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 1999
Dr. Andreas Petermann Requlatory Affairs ESPE DENTAL AG ESPE Platz D-82229 Seefeld Bavaria, Germany
Re : K990763 Vitron® M Trade Name: Regulatory Class: II Product Code: EBI March 3, 1999 Dated: Received: March 8, 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, labeling, 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 requlations 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) requlation (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 Reqister.
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Page 2 - Dr. Petermann
Please note: this response to your premarket notification submission does not affect any obligation you might 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,
Patricia Cucurullo
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® M
Indications for use:
Denture base material for: Completion of metal frameworks Partial and total denture rebasing Extension of partial dentures Repairs Fabrication of partial and total dentures
Prescription use: 区
Over-the counter use □
Susan Kunz
(Division Si Division of Dental, Infection Control, and General Hospi r ´´´/k) Number