The following data is part of a premarket notification filed by Jensen Industries, Inc. with the FDA for Insync Zr High Translucency Zirconia.
| Device ID | K142043 |
| 510k Number | K142043 |
| Device Name: | INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA |
| Classification | Powder, Porcelain |
| Applicant | JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473 |
| Contact | Jordan Schreck |
| Correspondent | Jordan Schreck JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-28 |
| Decision Date | 2014-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817340023206 | K142043 | 000 |
| 00817340025606 | K142043 | 000 |
| 00817340025590 | K142043 | 000 |
| 00817340025583 | K142043 | 000 |
| 00817340025576 | K142043 | 000 |
| 00817340025569 | K142043 | 000 |
| 00817340025552 | K142043 | 000 |
| 00817340023282 | K142043 | 000 |
| 00817340023275 | K142043 | 000 |
| 00817340023268 | K142043 | 000 |
| 00817340023251 | K142043 | 000 |
| 00817340023244 | K142043 | 000 |
| 00817340023237 | K142043 | 000 |
| 00817340023220 | K142043 | 000 |
| 00817340025613 | K142043 | 000 |
| 00817340025620 | K142043 | 000 |
| 00817340025637 | K142043 | 000 |
| 00817340023190 | K142043 | 000 |
| 00817340023183 | K142043 | 000 |
| 00817340023176 | K142043 | 000 |
| 00817340023169 | K142043 | 000 |
| 00817340023152 | K142043 | 000 |
| 00817340023145 | K142043 | 000 |
| 00817340023138 | K142043 | 000 |
| 00817340022278 | K142043 | 000 |
| 00817340022261 | K142043 | 000 |
| 00817340022254 | K142043 | 000 |
| 00817340022247 | K142043 | 000 |
| 00817340022230 | K142043 | 000 |
| 00817340022223 | K142043 | 000 |
| 00817340023213 | K142043 | 000 |