The following data is part of a premarket notification filed by B&d Dental Technologies with the FDA for Origin Zirconia.
| Device ID | K110719 |
| 510k Number | K110719 |
| Device Name: | ORIGIN ZIRCONIA |
| Classification | Powder, Porcelain |
| Applicant | B&D DENTAL TECHNOLOGIES 2371 S. PRESIDENTS DR., STE. E West Valley, UT 84119 |
| Contact | Joon Hwang |
| Correspondent | Joon Hwang B&D DENTAL TECHNOLOGIES 2371 S. PRESIDENTS DR., STE. E West Valley, UT 84119 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-15 |
| Decision Date | 2011-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D960BPMA1141 | K110719 | 000 |
| 00304040132982 | K110719 | 000 |
| 00304040132999 | K110719 | 000 |
| 00304040133019 | K110719 | 000 |
| 00304040133026 | K110719 | 000 |
| 00304040133033 | K110719 | 000 |
| 00304040133040 | K110719 | 000 |
| 00304040133057 | K110719 | 000 |
| 00304040133064 | K110719 | 000 |
| 00304040133088 | K110719 | 000 |
| 00304040133095 | K110719 | 000 |
| 00304040133101 | K110719 | 000 |
| 00304040133118 | K110719 | 000 |
| 00304040133125 | K110719 | 000 |
| 00304040133149 | K110719 | 000 |
| 00304040133156 | K110719 | 000 |
| 00304040132975 | K110719 | 000 |
| 00304040132944 | K110719 | 000 |
| D960BPMA2141 | K110719 | 000 |
| D960BPMA3141 | K110719 | 000 |
| D960BPMA4141 | K110719 | 000 |
| D960BPMA5141 | K110719 | 000 |
| D960BPMB1141 | K110719 | 000 |
| D960BPMB2141 | K110719 | 000 |
| D960BPMB3141 | K110719 | 000 |
| D960BPMB4141 | K110719 | 000 |
| D960BPMC1141 | K110719 | 000 |
| D960BPMC2141 | K110719 | 000 |
| 00304040132890 | K110719 | 000 |
| 00304040132906 | K110719 | 000 |
| 00304040132913 | K110719 | 000 |
| 00304040132920 | K110719 | 000 |
| 00304040132937 | K110719 | 000 |
| 00304040133163 | K110719 | 000 |
| 00304040133194 | K110719 | 000 |
| 00304040133200 | K110719 | 000 |
| D960BPX00241 | K110719 | 000 |
| D960BPX00251 | K110719 | 000 |
| D960BPX00281 | K110719 | 000 |
| D960BPX00301 | K110719 | 000 |
| D960BPX00101 | K110719 | 000 |
| D960LVX00101 | K110719 | 000 |
| D960LVX00121 | K110719 | 000 |
| D960LVX00141 | K110719 | 000 |
| D960LVX00161 | K110719 | 000 |
| D960LVX00181 | K110719 | 000 |
| D960LVX00201 | K110719 | 000 |
| D960LVX00221 | K110719 | 000 |
| D960LVX00241 | K110719 | 000 |
| D960LVX00251 | K110719 | 000 |
| D960LVX00281 | K110719 | 000 |
| D960BPX00221 | K110719 | 000 |
| D960BPX00201 | K110719 | 000 |
| 00304040133231 | K110719 | 000 |
| 00304040133248 | K110719 | 000 |
| 00304040133255 | K110719 | 000 |
| 00304040133286 | K110719 | 000 |
| 00304040133309 | K110719 | 000 |
| 00304040133316 | K110719 | 000 |
| 00304040133323 | K110719 | 000 |
| 00304040133354 | K110719 | 000 |
| 00304040133361 | K110719 | 000 |
| 00304040133378 | K110719 | 000 |
| D960BPMM2141 | K110719 | 000 |
| D960BPX00121 | K110719 | 000 |
| D960BPX00141 | K110719 | 000 |
| D960BPX00161 | K110719 | 000 |
| D960BPX00181 | K110719 | 000 |
| D960LVX00301 | K110719 | 000 |