Surefire Pf+ (High Palladium Dental Casting Alloy for Porcelain Applications)
FDA 510(k) K950894 · Argen Precious Metals, Inc.
510(k) numberK950894
Submission
- Device name
- Surefire Pf+ (High Palladium Dental Casting Alloy for Porcelain Applications)
- Applicant
- Argen Precious Metals, Inc.
San Diego, CA, US - Received
- February 27, 1995
- Decision date
- March 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from American Dent-All, Inc.
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| K954362 | Argistar 74EJT · Traditional | 10/12/1995SE |
| K954404 | Aurolite 45EJT · Traditional | 10/07/1995SE |
| K954371 | Surefire SEJT · Traditional | 10/07/1995SE |
| K954368 | Argedent Bio 87 PFEJT · Traditional | 10/07/1995SE |
| K954367 | Argistar Bio 75PFEJT · Traditional | 10/07/1995SE |
| K954361 | Argenco 68MEJT · Traditional | 10/07/1995SE |
Questions and answers
When was Surefire Pf+ (High Palladium Dental Casting Alloy for Porcelain Applications) cleared by the FDA?
Surefire Pf+ (High Palladium Dental Casting Alloy for Porcelain Applications) (K950894) received a 510(k) decision of Substantially Equivalent on March 31, 1995, 32 days after the submission was received.
What is the product code of K950894?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.