Degubond 4
by Degussa Corp. 510(k)
Active
510(k) K951787
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK951787 | Date8 Jun 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EJT
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3060
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
Degubond 4 is a gold-based noble metal alloy device classified under product code EJT and regulation number 872.3060. It received FDA 510(k) clearance K951787 on June 8, 1995, and was found substantially equivalent to a predicate device. The device is intended for dental use as indicated by the advisory committee classification.
The device was submitted by Degussa Corp. from South Plainfield, New Jersey, and is registered under multiple FEI and registration numbers associated with the applicant. It is a Class II medical device with no indication of sterility, single-use status, MRI safety, or specific sizes provided in the data. No storage conditions or usage settings are specified in the available information.
Other devices from Degussa AG
Questions
AI-generated answers, 22 Sep 2026
What is Degubond 4 intended for?
Degubond 4 is intended for dental use, as indicated by its advisory committee classification under product code EJT and regulation number 872.3060, which pertains to dental alloy devices.
How was Degubond 4 cleared for market?
Degubond 4 received FDA 510(k) clearance under number K951787 on June 8, 1995, following a traditional review process where it was found substantially equivalent to a predicate device.
Is Degubond 4 sterile or single-use?
The provided data does not indicate whether Degubond 4 is sterile or designated for single-use; no sterility or single-use status is specified in the device information.
What sizes or models are available for Degubond 4?
No specific sizes, models, or reference numbers beyond the device name 'Degubond 4' are provided in the data, so available configurations cannot be determined from the given information.
How should Degubond 4 be stored?
No storage conditions are specified in the available device data, so recommended storage practices cannot be determined from the information provided.