Occlufast
by Zhermack Dental Production 510(k)
Active
510(k) K935889
Overview
Occlufast is a dental impression material, specifically an addition silicone for bite registration, as indicated by its device type and classification. It is a Class II medical device cleared through the FDA 510(k) process under product code ELW and regulation number 872.3660.
The device is supplied as a non-sterile, single-use material intended for use in dental clinical settings for procedures such as maximum intercuspidation bite registration, centric, protrusion or lateral registrations, gnathological evaluations, diagnostic evaluation of craniocervical mandibular disorders, and orthodontic centric occlusion. It is manufactured by Zhermack Dental Production and has no indicated MRI safety or sterility claims in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK935889 | Date23 Aug 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- ELW
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Zhermack Dental Production
Questions
What is Occlufast used for in dental procedures?
Occlufast is an addition silicone impression material used for bite registration procedures, including maximum intercuspidation, centric, protrusion, lateral registrations, gnathological evaluations, diagnostic assessment of craniocervical mandibular disorders, and orthodontic centric occlusion. It is intended for clinical use in dental settings to capture accurate occlusal relationships.
Is Occlufast sterile or non-sterile, and is it designed for single use or reuse?
Occlufast is supplied as a non-sterile material and is intended for single-use only. There are no indications of sterility or reprocessing instructions in the device data, so it should be discarded after one patient use to prevent cross-contamination and ensure material integrity.
How is Occlufast supplied and what regulatory pathway was used for its clearance?
Occlufast is supplied as a dental impression material for bite registration and received FDA 510(k) clearance under submission K935889. It is classified as a Class II device under product code ELW and regulation 872.3660, with a determination of substantial equivalence to a legally marketed predicate device.