The following data is part of a premarket notification filed by Vident with the FDA for Vita Vm 7, Model Nx77 Xxxx, Nx78xxxx, Nx79 Xxxx; Vita Vm 8, Model Vx60 Xxxx, Vx61 Xxxx, Vx62 Xxxx; Vita Vm 9, Model Nx98.
| Device ID | K060441 |
| 510k Number | K060441 |
| Device Name: | VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98 |
| Classification | Powder, Porcelain |
| Applicant | VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
| Contact | Barbara J Lewandowski |
| Correspondent | Barbara J Lewandowski VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-21 |
| Decision Date | 2006-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J017BV13BKS12V30 | K060441 | 000 |
| J017B42214120 | K060441 | 000 |
| J017BV9AOKV20 | K060441 | 000 |
| J017BV9OCK2M2V50 | K060441 | 000 |
| J017BV9OCKA2V40 | K060441 | 000 |
| J017BVMKOCS2M2V20 | K060441 | 000 |
| J017BVMKOCSA2V20 | K060441 | 000 |
| J017BLML2500 | K060441 | 000 |
| J017BLML500 | K060441 | 000 |
| J017BV13BK12CV30 | K060441 | 000 |
| J017BV13BK12PCV30 | K060441 | 000 |
| J017BV13BK12PV30 | K060441 | 000 |
| J017BV13BK12V30 | K060441 | 000 |
| J017BV13BKS12CV30 | K060441 | 000 |
| J017BV13BKS12PCV30 | K060441 | 000 |
| J017BV13BKS12PV30 | K060441 | 000 |
| J017B42211120 | K060441 | 000 |