The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 Mm X 6mm,8mm, Model 454-91001,454-91002 And 1.2/1.5mm X 6,8,10mm, M.
| Device ID | K061397 |
| 510k Number | K061397 |
| Device Name: | ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Contact | J. Edward Carchidi |
| Correspondent | J. Edward Carchidi ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-19 |
| Decision Date | 2006-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10614950006585 | K061397 | 000 |
| 10614950006431 | K061397 | 000 |
| 10614950006424 | K061397 | 000 |
| 10614950006417 | K061397 | 000 |
| 10614950006400 | K061397 | 000 |
| 10614950006394 | K061397 | 000 |
| 00614950006380 | K061397 | 000 |
| 00614950006373 | K061397 | 000 |
| 00614950006366 | K061397 | 000 |
| 00614950006359 | K061397 | 000 |
| 00614950006342 | K061397 | 000 |
| 00614950006335 | K061397 | 000 |
| 00614950000234 | K061397 | 000 |
| 10614950006448 | K061397 | 000 |
| 00614950006458 | K061397 | 000 |
| 10614950006578 | K061397 | 000 |
| 10614950006561 | K061397 | 000 |
| 10614950006554 | K061397 | 000 |
| 10614950006547 | K061397 | 000 |
| 10614950006530 | K061397 | 000 |
| 00614950006526 | K061397 | 000 |
| 00614950006519 | K061397 | 000 |
| 00614950006502 | K061397 | 000 |
| 00614950006496 | K061397 | 000 |
| 00614950006489 | K061397 | 000 |
| 00614950006472 | K061397 | 000 |
| 00614950006465 | K061397 | 000 |
| 00614950000227 | K061397 | 000 |