Primary Device ID | J014660334500 |
NIH Device Record Key | 914430a9-f262-4a8b-8ca7-5fc1685e9e51 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PALA cre-active, red, 3 g |
Version Model Number | 66033450 |
Catalog Number | 66033450 |
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 | J014660334500 [Primary] |
EBF | MATERIAL, TOOTH SHADE, RESIN |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2024-10-30 |
Device Publish Date | 2016-09-15 |
J014660993170 - Flexitime | 2025-06-18 Flexitime unlimited Dynamix Refill (1x2x380ml) |
J014660993180 - Flexitime | 2025-06-18 Flexitime unlimited 1 x (2x50ml) |
J014660993190 - Flexitime | 2025-06-18 Flexitime unlimited Dynamix Trial Kit |
J014660993200 - Flexitime | 2025-06-18 Flexitime unlimited 1x50ml |
J014660993210 - Flexitime | 2025-06-18 Flexitime unlimited Trial Kit |
J014661004810 - Flexitime | 2025-06-18 Flexitime unlimited Jumbo Pack 12x50ml |
J014660874240 - dima Print Teeth & Temp | 2025-02-05 dima Print Teeth & Temp A2/B2 1000g |
J014660874260 - dima Print Teeth & Temp | 2025-02-05 dima Print Teeth & Temp A3/A3.5 1000g |