Argedent Bio 87 PF
FDA 510(k) K954368 · Argen Precious Metals, Inc.
510(k) numberK954368
Submission
- Device name
- Argedent Bio 87 PF
- Applicant
- Argen Precious Metals, Inc.
San Diego, CA, US - Received
- September 15, 1995
- Decision date
- October 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K954371 | Surefire SEJT · Traditional | 10/07/1995SE |
| K954367 | Argistar Bio 75PFEJT · Traditional | 10/07/1995SE |
| K954361 | Argenco 68MEJT · Traditional | 10/07/1995SE |
| K954360 | Argesol 600EJT · Traditional | 10/07/1995SE |
Questions and answers
When was Argedent Bio 87 PF cleared by the FDA?
Argedent Bio 87 PF (K954368) received a 510(k) decision of Substantially Equivalent on October 7, 1995, 22 days after the submission was received.
What is the product code of K954368?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.