510(k) K844480
K844480 is an FDA 510(k) premarket notification submitted by Advanced Bio Systems, Inc. for the device "DENTAL ORAL CARE SYSTEMS & COMPONENTS". The FDA issued a decision of SN on June 19, 1985. The device falls under product code EBO (Denture Repair Kit), a Class II device regulated under 21 CFR 872.3570. Advanced Bio Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- June 19, 1985
- Date Received
- November 19, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Denture Repair Kit
- Device Class
- Class II
- Regulation Number
- 872.3570
- Review Panel
- DE
- Submission Type
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.