JOHNSON & JOHNSON STAINING REMOVING COMPOUND
FDA 510(k) clearance K864226 · decided 1987-05-01
Clearance details
- K-number
- K864226
- Device name
- JOHNSON & JOHNSON STAINING REMOVING COMPOUND
- Applicant
- Johnson & Johnson Professionals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-10-28
- Decision date
- 1987-05-01
- Days to decision
- 185 days
- Clearance type
- Traditional
- Product code
- EJR
- Device class
- 1
- Regulation number
- 872.6030
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- East Windsor, NJ, US
- Third-party review
- No
- Expedited review
- No
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| GC MI PASTE PLUS (K070854) | GC America, Inc. | 2007-04-12 |
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Recalls involving this device
No recalls on record reference this clearance.