Endo-Eze Motor and Handpiece
FDA 510(k) K992380 · Ultradent Products, Inc.
510(k) numberK992380
Submission
- Device name
- Endo-Eze Motor and Handpiece
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- July 16, 1999
- Decision date
- October 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Endo-Eze Motor and Handpiece cleared by the FDA?
Endo-Eze Motor and Handpiece (K992380) received a 510(k) decision of Substantially Equivalent on October 13, 1999, 89 days after the submission was received.
What is the product code of K992380?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.