Primary Device ID | J014660714800 |
NIH Device Record Key | 60d3d369-cada-4210-82ad-3751518ed9f9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Delara |
Version Model Number | 66071480 |
Catalog Number | 66071480 |
Company DUNS | 315666321 |
Company Name | Kulzer GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | J014660714800 [Primary] |
ELM | Denture, plastic, teeth |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-10-30 |
Device Publish Date | 2019-10-06 |
J014660815640 | Delara 8, A3/L32U, CE |
J014660781360 | LMC Delara A2 ALU Box |
J01466071890 | Delara 8, B1/32L, CE |
J014660718380 | Delara 8, C3/34U, CE |
J014660716890 | Delara 8, BL3/36L, CE |
J014660716880 | Delara 8, BL3/36U, CE |
J014660716870 | Delara 8, BL3/34L, CE |
J014660716860 | Delara 8, BL3/34U, CE |
J014660716850 | Delara 8, BL3/32L, CE |
J014660716840 | Delara 8, BL3/32U, CE |
J014660716830 | Delara 8, BL3/30L, CE |
J014660716820 | Delara 8, BL3/30U, CE |
J014660716810 | Delara 8, BL2/36L, CE |
J014660716800 | Delara 8, BL2/36U, CE |
J014660716790 | Delara 8, BL2/34L, CE |
J014660716780 | Delara 8, BL2/34U, CE |
J014660716770 | Delara 8, BL2/32L, CE |
J014660716760 | Delara 8, BL2/32U, CE |
J014660716750 | Delara 8, BL2/30L, CE |
J014660716740 | Delara 8, BL2/30U, CE |
J014660716730 | Delara 8, D4/36L, CE |
J014660716720 | Delara 8, D4/36U, CE |
J014660716710 | Delara 8, D4/34L, CE |
J014660716700 | Delara 8, D4/34U, CE |
J014660716690 | Delara 8, D4/32L, CE |
J014660716680 | Delara 8, D4/32U, CE |
J014660716670 | Delara 8, D4/30L, CE |
J014660716660 | Delara 8, D4/30U, CE |
J014660716650 | Delara 8, D3/36L, CE |
J014660716640 | Delara 8, D3/36U, CE |
J014660716630 | Delara 8, D3/34L, CE |
J014660716620 | Delara 8, D3/34U, CE |
J014660716610 | Delara 8, D3/32L, CE |
J014660716600 | Delara 8, D3/32U, CE |
J014660716590 | Delara 8, D3/30L, CE |
J014660716580 | Delara 8, D3/30U, CE |
J014660716570 | Delara 8, D2/36L, CE |
J014660716560 | Delara 8, D2/36U, CE |
J014660716550 | Delara 8, D2/34L, CE |
J014660716540 | Delara 8, D2/34U, CE |
J014660716530 | Delara 8, D2/32L, CE |
J014660716520 | Delara 8, D2/32U, CE |
J014660716510 | Delara 8, D2/30L, CE |
J014660716500 | Delara 8, D2/30U, CE |
J014660716490 | Delara 8, C4/36L, CE |
J014660716480 | Delara 8, C4/36U, CE |
J014660716470 | Delara 8, C4/34L, CE |
J014660716460 | Delara 8, C4/34U, CE |
J014660716450 | Delara 8, C4/32L, CE |
J014660716440 | Delara 8, C4/32U, CE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DELARA 98570903 not registered Live/Pending |
Delara Alpina, LLC 2024-05-28 |
DELARA 98509635 not registered Live/Pending |
A1 HOME COLLECTIONS LLC 2024-04-19 |
DELARA 90571029 not registered Live/Pending |
A1 Home Collections LLC 2021-03-10 |
DELARA 79214701 5521654 Live/Registered |
Kulzer GmbH 2017-06-27 |