Primary Device ID | J014660982800 |
NIH Device Record Key | cf4cb02d-29f8-4ebd-a0ed-2ef9f5bfd584 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | iBond Universal |
Version Model Number | 66098280 |
Catalog Number | 66098280 |
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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
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 |
xx@xx.xx | |
Phone | +1(800)431-1785 |
xx@xx.xx | |
Phone | +1(800)431-1785 |
xx@xx.xx | |
Phone | +1(800)431-1785 |
xx@xx.xx | |
Phone | +1(800)431-1785 |
xx@xx.xx | |
Phone | +1(800)431-1785 |
xx@xx.xx | |
Phone | +1(800)431-1785 |
xx@xx.xx | |
Phone | +1(800)431-1785 |
xx@xx.xx | |
Phone | +1(800)431-1785 |
xx@xx.xx | |
Phone | +1(800)431-1785 |
xx@xx.xx | |
Phone | +1(800)431-1785 |
xx@xx.xx | |
Phone | +1(800)431-1785 |
xx@xx.xx | |
Phone | +1(800)431-1785 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
HIBCC | J014660982800 [Primary] |
KLE | AGENT, TOOTH BONDING, RESIN |
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 | 2024-03-06 |
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 |