Amorphous Diamond Coated Drill
FDA 510(k) K990846 · Nobel Biocare Uas, Inc.
510(k) numberK990846
Submission
- Device name
- Amorphous Diamond Coated Drill
- Applicant
- Nobel Biocare Uas, Inc.
Yorba Linda, CA, US - Received
- March 15, 1999
- Decision date
- June 10, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K050444 | Nobelreplace Adapter, Model 32412NHA · Traditional | 07/07/2005SE |
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| K031345 | Nobel Direct, Models 30937, 30938DZE · Traditional | 07/24/2003SE |
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Questions and answers
When was Amorphous Diamond Coated Drill cleared by the FDA?
Amorphous Diamond Coated Drill (K990846) received a 510(k) decision of Substantially Equivalent on June 10, 1999, 87 days after the submission was received.
What is the product code of K990846?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.