Ionosit Base Liner
FDA 510(k) K935689 · Foremost Dental Mfg., Co.
510(k) numberK935689
Submission
- Device name
- Ionosit Base Liner
- Applicant
- Foremost Dental Mfg., Co.
Englewood, NJ, US - Received
- November 29, 1993
- Decision date
- January 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K954867 | Ionosit SealEBC · Traditional | 03/08/1996SE |
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Questions and answers
When was Ionosit Base Liner cleared by the FDA?
Ionosit Base Liner (K935689) received a 510(k) decision of Substantially Equivalent on January 21, 1994, 53 days after the submission was received.
What is the product code of K935689?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.