Degufill Adhesive
by Degussa AG 510(k)
Active
510(k) K901871
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK901871 | Date6 Aug 1990 | 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- Withdrawn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
- Full name
- Degufill (R) Adhesive
- 510(k) Number
- FDA Product Code
- KLE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3200
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
This device is an Agent, Tooth Bonding, Resin, as defined in the device type and definition from the nomenclature authority. It is a dental adhesive used for bonding applications.
It was cleared by the FDA via the 510(k) pathway under K901871, classified as Class II with product code KLE. The device is supplied by Degussa AG and received clearance on August 6, 1990, following a traditional 510(k) review.
Other devices from Degussa AG
Questions
AI-generated answers, 27 Sep 2026
What is DEGUFILL (R) ADHESIVE used for?
DEGUFILL (R) ADHESIVE is a dental adhesive used for bonding applications, specifically as an Agent, Tooth Bonding, Resin, to attach restorative materials to tooth structure in dental procedures.
How is DEGUFILL (R) ADHESIVE supplied and is it sterile or single-use?
The device data does not specify sterility, single-use status, or supply format for DEGUFILL (R) ADHESIVE; therefore, no details about its packaging, sterility, or reuse can be derived from the provided information.
What regulatory pathway cleared DEGUFILL (R) ADHESIVE and when was it cleared?
DEGUFILL (R) ADHESIVE was cleared by the FDA via the traditional 510(k) pathway under K901871 on August 6, 1990, following a determination of substantial equivalence to a predicate device.