The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Silkline Soft Relining Kit, Model 28-100100.
| Device ID | K060844 |
| 510k Number | K060844 |
| Device Name: | SILKLINE SOFT RELINING KIT, MODEL 28-100100 |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Contact | Howard Rowe |
| Correspondent | Howard Rowe J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-28 |
| Decision Date | 2006-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18522530060150 | K060844 | 000 |
| 18522530060143 | K060844 | 000 |
| 18522530060136 | K060844 | 000 |
| 10852253006172 | K060844 | 000 |
| 10852253006165 | K060844 | 000 |
| 10852253006158 | K060844 | 000 |
| 10852253006141 | K060844 | 000 |
| 10852253006134 | K060844 | 000 |