The following data is part of a premarket notification filed by Specialty Appliance Works, Inc. with the FDA for Clear Image Aligner.
| Device ID | K071970 |
| 510k Number | K071970 |
| Device Name: | CLEAR IMAGE ALIGNER |
| Classification | Aligner, Sequential |
| Applicant | SPECIALTY APPLIANCE WORKS, INC. 2193 SPEAR POINT DR. Marietta, GA 30062 |
| Contact | James W Kolka |
| Correspondent | James W Kolka SPECIALTY APPLIANCE WORKS, INC. 2193 SPEAR POINT DR. Marietta, GA 30062 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-17 |
| Decision Date | 2007-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D819702100 | K071970 | 000 |
| D819700410 | K071970 | 000 |