(84 days)
K 954281, K 960547, K 953374
Not Found
No
The device description and intended use clearly state it is an impression material, and there is no mention of AI, ML, or any computational processing of data.
No
The device is classified as an impression material intended to reproduce the structure of a patient's teeth; it is not designed to treat, cure, or prevent any disease or condition.
No
The device is described as an impression material intended to reproduce the structure of a patient's teeth for bite registration, not to diagnose a condition.
No
The device is described as an "impression material" and its description focuses on its chemical composition and physical properties, comparing it to other impression materials. This indicates it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are "Bite registration" and "Intraoral guide pin excursion tracing." These are procedures performed directly on the patient's teeth to record their structure and relationship.
- Device Description: It is classified as an "impression material" intended to "reproduce the structure of a patient's teeth." This is a physical process of creating a mold of the teeth.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of bodily specimens.
The description clearly indicates a device used for a physical procedure within the patient's mouth, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
Bite registration
Intraoral guide pin excursion tracing
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
DIMENSION® BITE is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth.
DIMENSION® BITE is similar in intended use and substantially equivalent to Roydent's polyvinyl siloxane based impression and bite registration material PANASIL® and ESPE's polyvinyl siloxane based impression material DIMENSION® PENTA.
In recent years ESPE was already marketing a bite registration material tradenamed DIMENSION® BITE in USA. This material is a private label product and manufactured by Kettenbach. The same device is marketed in USA under the name FUTAR® OCCLUSION by Roydent. Roydent holds the 510(k) for the material (K 954281). To be independent from suppliers, ESPE decided to develop an own polyvinyl siloxane based bite registration material which will replace the private label material.
The basis for ESPE's new development is the good experience with its addition type silicone based impression material DIMENSION® PENTA.
The physical and mechanical properties of the new DIMENSION® BITE have been compared to those of the old DIMENSION® BITE (FUTAR® OCCLUSION).
The composition of the new DIMENSION® BITE contains the same ingredients as ESPE's DIMENSION® PENTA® impression material except one softening agent which is contained in ESPE's polyether based impression material PERMADYNE® GArant®.
The above mentioned impression and bite registration materials are well established and considered to be safe and effective.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth
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)
The physical and mechanical properties of the new DIMENSION® BITE have been compared to those of the old DIMENSION® BITE (FUTAR® OCCLUSION).
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 954281, K 960547, K 953374
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
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
0
Kaa locy
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 |
Name of Device
| Proprietary Name: | DIMENSION® BITE |
|---|---|
| Classification Name: | Impression material |
| Common Name: | Bite registration material |
Predicate Devices
| PANASIL® by Roydent | K 954281 |
|---|---|
| DIMENSION® PENTA by ESPE | K 960547 |
| PERMADYNE® GARANT® by ESPE | K 953374 |
Description for the Premarket Notification
DIMENSION® BITE is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth.
DIMENSION® BITE is similar in intended use and substantially equivalent to Roydent's polyvinyl siloxane based impression and bite registration material PANASIL® and ESPE's polyvinyl siloxane based impression material DIMENSION® PENTA.
In recent years ESPE was already marketing a bite registration material tradenamed DIMENSION® BITE in USA. This material is a private label product and
Image /page/0/Picture/13 description: The image shows the logo for 510(k) DIMENSION® BITE. The logo features the text "510(k) DIMENSION® BITE" in a sans-serif font. Below the text is a logo with a tree on the left and the word "ESPE" on the right.
1
manufactured by Kettenbach. The same device is marketed in USA under the name FUTAR® OCCLUSION by Roydent. Roydent holds the 510(k) for the material (K 954281). To be independent from suppliers, ESPE decided to develop an own polyvinyl siloxane based bite registration material which will replace the private label material.
The basis for ESPE's new development is the good experience with its addition type silicone based impression material DIMENSION® PENTA.
The physical and mechanical properties of the new DIMENSION® BITE have been compared to those of the old DIMENSION® BITE (FUTAR® OCCLUSION).
The composition of the new DIMENSION® BITE contains the same ingredients as ESPE's DIMENSION® PENTA® impression material except one softening agent which is contained in ESPE's polyether based impression material PERMADYNE® GArant®.
The above mentioned impression and bite registration materials are well established and considered to be safe and effective.
Image /page/1/Picture/5 description: The image shows the logo for 510(k) DIMENSION Bite. The logo features a stylized leaf design to the left of the word "ESPE". The text is in a simple, sans-serif font and is arranged in a stacked format.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines forming its body and wings.
JUN 18 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: K991008 DIMENSION® BRITE Trade Name: Requlatory Class: II Product Code: ELW Dated: March 24, 1999 March 26, 1999 Received:
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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ 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 Requster.
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Page 2 - Dr. Petermann
this response to your premarket notification Please note: 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
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE III.
. .
Device Name:
DIMENSION® BITE
Indications for use:
Bite registration
Intraoral guide pin excursion tracing
Prescription Use
(Per 21 CFR 801.109)
Susa Rurr
(Division Sign-Off) Division of Dental, Infection Control, Division of Dental, Infecti
and General Hospital Dey
510(k) Number 510(k) Number _
Image /page/4/Picture/9 description: The image shows the logo for 510(k) DIMENSION® BITE. The logo consists of the text "510(k) DIMENSION® BITE" in a sans-serif font. Below the text is the logo for ESPE, which consists of a stylized tree inside of a square, followed by the text "ESPE" in a bold sans-serif font.