The following data is part of a premarket notification filed by Ortho Kinetics Corp. with the FDA for Facebow.
| Device ID | K980195 |
| 510k Number | K980195 |
| Device Name: | FACEBOW |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | ORTHO KINETICS CORP. 1611A SOUTH MELROSE DR. SUITE 16 Vista, CA 92083 -5407 |
| Contact | Steven O Luse |
| Correspondent | Steven O Luse ORTHO KINETICS CORP. 1611A SOUTH MELROSE DR. SUITE 16 Vista, CA 92083 -5407 |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-20 |
| Decision Date | 1998-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040027073 | K980195 | 000 |
| 00190707009298 | K980195 | 000 |
| 00190707009281 | K980195 | 000 |
| 00190707009274 | K980195 | 000 |
| 00190707009267 | K980195 | 000 |
| 00190707009250 | K980195 | 000 |
| 00190707009243 | K980195 | 000 |
| 00190707009236 | K980195 | 000 |
| 00190707009229 | K980195 | 000 |
| 00190707009212 | K980195 | 000 |
| 00190707009205 | K980195 | 000 |
| 00190707009199 | K980195 | 000 |
| 00190707009182 | K980195 | 000 |
| 00190707009175 | K980195 | 000 |
| 00190707000615 | K980195 | 000 |
| 00190707000561 | K980195 | 000 |
| 00190707009304 | K980195 | 000 |
| 00190707009311 | K980195 | 000 |
| 00190707009328 | K980195 | 000 |
| 00304040027066 | K980195 | 000 |
| 00304040027059 | K980195 | 000 |
| 00304040027042 | K980195 | 000 |
| 00304040027035 | K980195 | 000 |
| 00304040027028 | K980195 | 000 |
| 00304040027011 | K980195 | 000 |
| 00304040027004 | K980195 | 000 |
| 00190730004581 | K980195 | 000 |
| 00190730004574 | K980195 | 000 |
| 00190730004567 | K980195 | 000 |
| 00190730004550 | K980195 | 000 |
| 00190730004543 | K980195 | 000 |
| 00190730004536 | K980195 | 000 |
| 00190730004529 | K980195 | 000 |
| 00190707009335 | K980195 | 000 |
| 00190707000554 | K980195 | 000 |