Primary Device ID | J014669704740 |
NIH Device Record Key | d08837af-0117-4851-8e0e-791f0f4b27b7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Mondial 6i, A1 / L16, CE |
Version Model Number | 66970474 |
Catalog Number | 66970474 |
Company DUNS | 315666321 |
Company Name | Kulzer GmbH |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
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 |
Phone | +1(800)431-1785 |
xxx@xxx.xxx | |
Phone | +1(800)431-1785 |
xxx@xxx.xxx | |
Phone | +1(800)431-1785 |
xxx@xxx.xxx | |
Phone | +1(800)431-1785 |
xxx@xxx.xxx | |
Phone | +1(800)431-1785 |
xxx@xxx.xxx | |
Phone | +1(800)431-1785 |
xxx@xxx.xxx | |
Phone | +1(800)431-1785 |
xxx@xxx.xxx | |
Phone | +1(800)431-1785 |
xxx@xxx.xxx | |
Phone | +1(800)431-1785 |
xxx@xxx.xxx | |
Phone | +1(800)431-1785 |
xxx@xxx.xxx | |
Phone | +1(800)431-1785 |
xxx@xxx.xxx | |
Phone | +1(800)431-1785 |
xxx@xxx.xxx | |
Phone | +1(800)431-1785 |
xxx@xxx.xxx |
Device Issuing Agency | Device ID |
---|---|
HIBCC | J014669704740 [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 | 3 |
Public Version Date | 2024-10-30 |
Device Publish Date | 2016-09-15 |
J01466081670 - Dima | 2024-11-07 dima Print Denture - Light Reddish Pink |
J01466081673 - Dima | 2024-11-07 dima Print Denture - Dark Pink |
J01466081678 - Dima | 2024-11-07 dima Print Denture Teeth - B1 |
J01466087415 - Dima | 2024-11-07 dima Print Denture Teeth - BL1 |
J014661002680 - VENUS Diamond FLOW | 2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - LIGHT |
J014661002690 - VENUS Diamond FLOW | 2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - MEDIUM |
J014661002700 - VENUS Diamond FLOW | 2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - DARK |
J014661002710 - VENUS Diamond FLOW | 2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - BLEACH |