Composite/Compomer Repair Kit
FDA 510(k) K041960 · Dmg USA, Inc.
510(k) numberK041960
Submission
- Device name
- Composite/Compomer Repair Kit
- Applicant
- Dmg USA, Inc.
Dover, DE, US - Received
- July 21, 2004
- Decision date
- August 30, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Composite/Compomer Repair Kit cleared by the FDA?
Composite/Compomer Repair Kit (K041960) received a 510(k) decision of Substantially Equivalent on August 30, 2004, 40 days after the submission was received.
What is the product code of K041960?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.