Primary Device ID | E217142061 |
NIH Device Record Key | 1eb77e96-f2a8-43ed-9c81-eb4c66b33ff2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Universal Adhesive |
Version Model Number | 14206 |
Catalog Number | 14206 |
Company DUNS | 316803246 |
Company Name | Kettenbach GmbH & Co. KG |
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 | true |
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 | E217142061 [Primary] |
EBH | Material, Impression Tray, Resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-07 |
Device Publish Date | 2023-05-30 |
E217119231 - Futar | 2025-08-22 Futar Easy Normal pack |
E217119241 - Futar | 2025-08-22 Futar Easy Fast Normal pack |
E217172261 - Mixing Tips | 2025-08-22 Mixing tips, grey, 50 tips |
E21711928111 - Futar | 2025-08-15 Futar Clear Fast Normal pack |
E217220111 - Mixing Tips | 2025-08-15 Mixing tips, red, ø 4.0 mm 8 tips |
E217220201 - Mixing Tips | 2025-08-15 Mixing tips, blue, ø 6.0 mm 6 tips |
E217150221 - Application Tips | 2025-04-11 Application Tips for Visalys Bulk Flow, 50 tips, Ø 0.9 mm |
E217150231 - Application Tips | 2025-04-11 Application Tips for Visalys Bulk Flow, 50 tips, Ø 1.2 mm |