The following data is part of a premarket notification filed by Iq Implants Ltd. with the FDA for Iq Implants; Iq Implants; Iq Implants Abutments.
| Device ID | K130829 |
| 510k Number | K130829 |
| Device Name: | IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IQ IMPLANTS LTD. TAASHUR 9 Omer, IL 84965 |
| Contact | Natalia Dinersthein |
| Correspondent | Natalia Dinersthein IQ IMPLANTS LTD. TAASHUR 9 Omer, IL 84965 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-26 |
| Decision Date | 2013-11-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D777SM6001151 | K130829 | 000 |
| D777SM4200081 | K130829 | 000 |
| D777SM3751151 | K130829 | 000 |
| D777SM3750161 | K130829 | 000 |
| D777SM3750131 | K130829 | 000 |
| D777SM3750101 | K130829 | 000 |
| D777SM3750081 | K130829 | 000 |
| D777SM3201151 | K130829 | 000 |
| D777SM3200161 | K130829 | 000 |
| D777SM3200131 | K130829 | 000 |
| D777SM3200101 | K130829 | 000 |
| D777SM4200101 | K130829 | 000 |
| D777SM4200131 | K130829 | 000 |
| D777SM6000131 | K130829 | 000 |
| D777SM6000101 | K130829 | 000 |
| D777SM6000081 | K130829 | 000 |
| D777SM5001151 | K130829 | 000 |
| D777SM5000161 | K130829 | 000 |
| D777SM5000131 | K130829 | 000 |
| D777SM5000101 | K130829 | 000 |
| D777SM5000081 | K130829 | 000 |
| D777SM4201151 | K130829 | 000 |
| D777SM4200161 | K130829 | 000 |
| D777SM3200081 | K130829 | 000 |