3M Clinpro Prophy Paste, Model 12611
FDA 510(k) K990482 · Minnesota Mining and Mfg. Co.
510(k) numberK990482
Submission
- Device name
- 3M Clinpro Prophy Paste, Model 12611
- Applicant
- Minnesota Mining and Mfg. Co.
St. Paul, MN, US - Received
- February 16, 1999
- Decision date
- May 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was 3M Clinpro Prophy Paste, Model 12611 cleared by the FDA?
3M Clinpro Prophy Paste, Model 12611 (K990482) received a 510(k) decision of Substantially Equivalent on May 13, 1999, 86 days after the submission was received.
What is the product code of K990482?
The FDA product code is EJR – Agent, Polishing, Abrasive, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6030.