Perfect Tissue Contouring System II
FDA 510(k) K071632 · Coltene/Whaledent, Inc.
510(k) numberK071632
Submission
- Device name
- Perfect Tissue Contouring System II
- Applicant
- Coltene/Whaledent, Inc.
Cuyahoga Falls, OH, US - Received
- June 14, 2007
- Decision date
- October 18, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Perfect Tissue Contouring System II cleared by the FDA?
Perfect Tissue Contouring System II (K071632) received a 510(k) decision of Substantially Equivalent on October 18, 2007, 126 days after the submission was received.
What is the product code of K071632?
The FDA product code is EKZ – Unit, Electrosurgical, And Accessories, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.4920.