IMPROVED TRY-IN GEL— 510(k) K001899
Substantially EquivalentSybron Dental Specialties, Inc.
FDA 510(k) clearance K001899 for IMPROVED TRY-IN GEL, Substantially Equivalent on 2000-08-28. Applicant: Sybron Dental Specialties, Inc.. Device class: 2.
Clearance details
- Applicant
- Sybron Dental Specialties, Inc.
- Product code
- Code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orange, CA, US
Recent devices under product code EBF
view allMore clearances from Sybron Dental Specialties, Inc.
view allRecalls naming K001899
K-number listed on FDA's recall record- Z-1824-2020 — Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations to implant abutments.
- Z-2259-2013 — NX3 Try-In Gel. The product is used as a tooth shade resin material.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001899.
Data sourced from openFDA. This site is unofficial and independent of the FDA.