The following data is part of a premarket notification filed by Intra-lock International, Inc. with the FDA for Intra-lock Dental Implants With Blossom.
| Device ID | K103194 |
| 510k Number | K103194 |
| Device Name: | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INTRA-LOCK INTERNATIONAL, INC. 6560 WEST ROGERS CIRCLE Boca Raton, FL 33487 |
| Contact | Angela Blackwell |
| Correspondent | Angela Blackwell INTRA-LOCK INTERNATIONAL, INC. 6560 WEST ROGERS CIRCLE Boca Raton, FL 33487 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-29 |
| Decision Date | 2011-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D742IAA030 | K103194 | 000 |
| D742SAA250 | K103194 | 000 |
| D742SHAW60 | K103194 | 000 |
| D742ISSAN0 | K103194 | 000 |
| D742IAA15P10 | K103194 | 000 |
| D742IAA15P30 | K103194 | 000 |
| D742IAA25P10 | K103194 | 000 |
| D742IAA25P30 | K103194 | 000 |
| D742ISAA1530 | K103194 | 000 |
| D742ISAA250 | K103194 | 000 |
| D742ISAA2530 | K103194 | 000 |
| D742ISBA40 | K103194 | 000 |
| D742ISSA50 | K103194 | 000 |
| D742SAA1520 | K103194 | 000 |
| D742SAA150 | K103194 | 000 |
| D742IAA0W10 | K103194 | 000 |
| D742S47100 | K103194 | 000 |
| D742S47110 | K103194 | 000 |
| D742IFANT0 | K103194 | 000 |
| D742IFAT0 | K103194 | 000 |
| D742IAA010 | K103194 | 000 |
| D742SFAW20 | K103194 | 000 |
| D742SFAW10 | K103194 | 000 |
| D742SFAW30 | K103194 | 000 |
| D742IAA0F10 | K103194 | 000 |
| D742IAA0F30 | K103194 | 000 |
| D742IAA0F50 | K103194 | 000 |
| D742S60080 | K103194 | 000 |
| D742S60100 | K103194 | 000 |
| D742S47060 | K103194 | 000 |
| D742I6006STI0 | K103194 | 000 |
| D742I6008STI0 | K103194 | 000 |
| D742I6010STI0 | K103194 | 000 |
| D742I6011STI0 | K103194 | 000 |
| D742IS3408TI0 | K103194 | 000 |
| D742IS3410TI0 | K103194 | 000 |
| D742IS3415TI0 | K103194 | 000 |
| D742OPCA0 | K103194 | 000 |
| D742OPCAS0 | K103194 | 000 |
| D742S15NM0 | K103194 | 000 |
| D742SCAA170 | K103194 | 000 |
| D742SGC0 | K103194 | 000 |
| D742I4713STI0 | K103194 | 000 |
| D742I4711STI0 | K103194 | 000 |
| D742S47080 | K103194 | 000 |
| D742S60060 | K103194 | 000 |
| D742IS3411TI0 | K103194 | 000 |
| D742IS3413TI0 | K103194 | 000 |
| D742IS3710TI0 | K103194 | 000 |
| D742BL4008STI0 | K103194 | 000 |
| D742BLCT4010S0 | K103194 | 000 |
| D742BLCT4011S0 | K103194 | 000 |
| D742BLCT4013S0 | K103194 | 000 |
| D742BLCT4015S0 | K103194 | 000 |
| D742I4708STI0 | K103194 | 000 |
| D742I4710STI0 | K103194 | 000 |
| D742DT4011TI0 | K103194 | 000 |