510(k) K853160
K853160 is an FDA 510(k) premarket notification submitted by Austenal Dental, Inc. for the device "AUSTENAL MODIFIED ACRYLIC DENTURE RESIN". The FDA issued a decision of Substantially Equivalent on October 31, 1985. The device falls under product code ELM (Denture, Plastic, Teeth), a Class II device regulated under 21 CFR 872.3590. Austenal Dental, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1985
- Date Received
- July 30, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Denture, Plastic, Teeth
- Device Class
- Class II
- Regulation Number
- 872.3590
- Review Panel
- DE
- Submission Type