Optiblast Intraoral Sandblaster
FDA 510(k) K955573 · Buffalo Dental Mfg. Co., Inc.
510(k) numberK955573
Submission
- Device name
- Optiblast Intraoral Sandblaster
- Applicant
- Buffalo Dental Mfg. Co., Inc.
Syosset, NY, US - Received
- December 7, 1995
- Decision date
- May 3, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K802990 | Alginate/Silicone Crown & Bridge MaterELW · Traditional | 02/02/1981SE |
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Questions and answers
When was Optiblast Intraoral Sandblaster cleared by the FDA?
Optiblast Intraoral Sandblaster (K955573) received a 510(k) decision of Substantially Equivalent on May 3, 1996, 148 days after the submission was received.
What is the product code of K955573?
The FDA product code is KOJ – Airbrush, a Class II (moderate risk) device regulated under 21 CFR 872.6080.