Sebond Pink Light 5G, Sebond Pink Dark 5G, Sebond Smart 5ML, Sebond Grip 3G, Models 644090, 644091, 640066, 644092
FDA 510(k) K051050 · Schutz-Dental GmbH
510(k) numberK051050
Submission
- Device name
- Sebond Pink Light 5G, Sebond Pink Dark 5G, Sebond Smart 5ML, Sebond Grip 3G, Models 644090, 644091, 640066, 644092
- Applicant
- Schutz-Dental GmbH
Rosbach, DE - Received
- April 25, 2005
- Decision date
- June 29, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Sebond Pink Light 5G, Sebond Pink Dark 5G, Sebond Smart 5ML, Sebond Grip 3G, Models 644090, 644091, 640066, 644092 cleared by the FDA?
Sebond Pink Light 5G, Sebond Pink Dark 5G, Sebond Smart 5ML, Sebond Grip 3G, Models 644090, 644091, 640066, 644092 (K051050) received a 510(k) decision of Substantially Equivalent on June 29, 2005, 65 days after the submission was received.
What is the product code of K051050?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.