Ultra-Blend Plus
FDA 510(k) K970113 · Ultradent Products, Inc.
510(k) numberK970113
Submission
- Device name
- Ultra-Blend Plus
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- January 13, 1997
- Decision date
- April 2, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Ultra-Blend Plus cleared by the FDA?
Ultra-Blend Plus (K970113) received a 510(k) decision of Substantially Equivalent on April 2, 1997, 79 days after the submission was received.
What is the product code of K970113?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.