The following data is part of a premarket notification filed by Hdc S.r.l. with the FDA for Hdc Sterile Self Ligating Spider Screw, Model Sli,sl2.
| Device ID | K091390 |
| 510k Number | K091390 |
| Device Name: | HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | HDC S.R.L. VIA BORGO SANTA CRISTINA,12 Imola, Bologna, IT 4026 |
| Contact | Guido Bonapace |
| Correspondent | Guido Bonapace HDC S.R.L. VIA BORGO SANTA CRISTINA,12 Imola, Bologna, IT 4026 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-11 |
| Decision Date | 2009-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057013140102 | K091390 | 000 |
| 08057013140829 | K091390 | 000 |
| 08057013140812 | K091390 | 000 |
| 08057013140805 | K091390 | 000 |
| 08057013140799 | K091390 | 000 |
| 08057013140775 | K091390 | 000 |
| 08057013140768 | K091390 | 000 |
| 08057013140751 | K091390 | 000 |