M.L. Primer
FDA 510(k) K040079 · Shofu Dental Corp.
510(k) numberK040079
Submission
- Device name
- M.L. Primer
- Applicant
- Shofu Dental Corp.
San Marcos, CA, US - Received
- January 15, 2004
- Decision date
- September 9, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was M.L. Primer cleared by the FDA?
M.L. Primer (K040079) received a 510(k) decision of Substantially Equivalent on September 9, 2004, 238 days after the submission was received.
What is the product code of K040079?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.