Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)— 510(k) K213244
Substantially EquivalentPrevest Denpro Limited
FDA 510(k) clearance K213244 for Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration), Substantially Equivalent on 2022-09-09. Applicant: Prevest Denpro Limited. Device class: 2.
Clearance details
- Applicant
- Prevest Denpro Limited
- Product code
- Code ELW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bari Brahmana, IN
Recent devices under product code ELW
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- K241924 — Elastic Impression Material
- K242360 — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
More clearances from Prevest Denpro Limited
view all- K233273 — C&B Ceramic; C&B Permanent; C&B Interim
- K231263 — Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
- K231696 — Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
- K212563 — CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
- K212475 — Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
Data sourced from openFDA. This site is unofficial and independent of the FDA.