Reveneer Ceramic Repair System
FDA 510(k) K052189 · Schutz-Dental GmbH
510(k) numberK052189
Submission
- Device name
- Reveneer Ceramic Repair System
- Applicant
- Schutz-Dental GmbH
Rosbach, DE - Received
- August 11, 2005
- Decision date
- October 17, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Reveneer Ceramic Repair System cleared by the FDA?
Reveneer Ceramic Repair System (K052189) received a 510(k) decision of Substantially Equivalent on October 17, 2005, 67 days after the submission was received.
What is the product code of K052189?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.