510(k) K931204
K931204 is an FDA 510(k) premarket notification submitted by Den-Tal-Ez Mfg Co., Inc. for the device "AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM)". The FDA issued a decision of Substantially Equivalent on July 8, 1993. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Den-Tal-Ez Mfg Co., Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 1993
- Date Received
- March 9, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type