510(k) K830491
K830491 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "JOHNSON & JOHNSON OPAQUE COLOR MODIFI". The FDA issued a decision of Substantially Equivalent on March 17, 1983. The device falls under product code EBE (Coating, Denture Hydrophilic, Resin), a Class II device regulated under 21 CFR 872.3300. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1983
- Date Received
- February 15, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Denture Hydrophilic, Resin
- Device Class
- Class II
- Regulation Number
- 872.3300
- Review Panel
- DE
- Submission Type