| 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 |