The following data is part of a premarket notification filed by Digitek Dental Solutions Limited with the FDA for Digitek Titanium Abutment.
| Device ID | K141970 |
| 510k Number | K141970 |
| Device Name: | DIGITEK TITANIUM ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | DIGITEK DENTAL SOLUTIONS LIMITED 93 KINGLAM ST, CHEUNG SHA WAN UNITS B-C FLAT D, 6/F Kowloon, Hong Kong, CN 999077 |
| Contact | Alwin Ngai |
| Correspondent | Alwin Ngai DIGITEK DENTAL SOLUTIONS LIMITED 93 KINGLAM ST, CHEUNG SHA WAN UNITS B-C FLAT D, 6/F Kowloon, Hong Kong, CN 999077 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-21 |
| Decision Date | 2015-07-31 |
| Summary: | summary |