The following data is part of a premarket notification filed by Basic Dental Implant Systems, Inc. with the FDA for Omni-tight.
| Device ID | K082749 |
| 510k Number | K082749 |
| Device Name: | OMNI-TIGHT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BASIC DENTAL IMPLANT SYSTEMS, INC. 3321 COLUMBIA N.E. Albuquerque, NM 87107 -2001 |
| Contact | Dan Blacklock |
| Correspondent | Dan Blacklock BASIC DENTAL IMPLANT SYSTEMS, INC. 3321 COLUMBIA N.E. Albuquerque, NM 87107 -2001 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-19 |
| Decision Date | 2008-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810123450008 | K082749 | 000 |
| 00810123452736 | K082749 | 000 |
| 00810123452729 | K082749 | 000 |
| 00810123452712 | K082749 | 000 |
| 00810123452705 | K082749 | 000 |
| 00810123452699 | K082749 | 000 |
| 00810123452682 | K082749 | 000 |
| 00810123452675 | K082749 | 000 |
| 00810123452668 | K082749 | 000 |
| 00810123452651 | K082749 | 000 |
| 00810123452644 | K082749 | 000 |
| 00810123452637 | K082749 | 000 |
| 00810123452620 | K082749 | 000 |
| 00810123452613 | K082749 | 000 |
| 00810123452606 | K082749 | 000 |
| 00810123452590 | K082749 | 000 |
| 00810123452583 | K082749 | 000 |
| 00810123450015 | K082749 | 000 |
| 00810123450022 | K082749 | 000 |
| 00810123450039 | K082749 | 000 |
| 00810123450190 | K082749 | 000 |
| 00810123450183 | K082749 | 000 |
| 00810123450176 | K082749 | 000 |
| 00810123450169 | K082749 | 000 |
| 00810123450152 | K082749 | 000 |
| 00810123450145 | K082749 | 000 |
| 00810123450138 | K082749 | 000 |
| 00810123450121 | K082749 | 000 |
| 00810123450114 | K082749 | 000 |
| 00810123450107 | K082749 | 000 |
| 00810123450091 | K082749 | 000 |
| 00810123450084 | K082749 | 000 |
| 00810123450077 | K082749 | 000 |
| 00810123450060 | K082749 | 000 |
| 00810123450053 | K082749 | 000 |
| 00810123450046 | K082749 | 000 |
| 00810123452576 | K082749 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OMNI-TIGHT 76168947 2658034 Live/Registered |
Basic Dental Implant Systems, Inc. 2000-11-20 |