510(k) K914257
K914257 is an FDA 510(k) premarket notification submitted by Essential Dental Systems, Inc. for the device "DENTURE PRODUCT X". The FDA issued a decision of Substantially Equivalent on January 13, 1993. The device falls under product code EFT (Cleanser, Denture, Over The Counter), a Class I device regulated under 21 CFR 872.3520. Essential Dental Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1993
- Date Received
- September 23, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleanser, Denture, Over The Counter
- Device Class
- Class I
- Regulation Number
- 872.3520
- Review Panel
- DE
- Submission Type