REVENEER CERAMIC REPAIR SYSTEM— 510(k) K052189
Substantially EquivalentSchutz-Dental GmbH
FDA 510(k) clearance K052189 for REVENEER CERAMIC REPAIR SYSTEM, Substantially Equivalent on 2005-10-17. Applicant: Schutz-Dental GmbH. Device class: 2.
Clearance details
- Applicant
- Schutz-Dental GmbH
- Product code
- Code KLE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rosbach, DE
Recent devices under product code KLE
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- K071010 — TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS
- K052073 — FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000
- K051050 — SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092
Data sourced from openFDA. This site is unofficial and independent of the FDA.