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 |
E217148071 - Profisil | 2023-12-13 Profisil Fluoride Varnish Mint, Bulk Pack, 300 x 0,5 ml, Mint |
E217148081 - Profisil | 2023-12-13 Profisil Fluoride Varnish Berry, Bulk Pack, 300 x 0,5 ml, Berry |
E217148091 - Profisil | 2023-12-13 Profisil Fluoride Varnish Unflavored, Bulk Pack, 300 x 0,5 ml, Unflavored |
E217148001 - Profisil | 2023-08-09 Profisil® Fluoride Varnish Sample pack, 6 x 0,5 ml (2 x Mint, 2 x Berry, 2 x Unflavored) |
E217148011 - Profisil | 2023-08-09 Profisil® Fluoride Varnish Combi pack |
E217148021 - Profisil | 2023-08-09 Profisil® Fluoride Varnish Normal pack, 50 x 0.5 ml Mint |
E217148041 - Profisil | 2023-08-09 Profisil® Fluoride Varnish Normal pack, 50 x 0.5 ml Berry |
E217148061 - Profisil | 2023-08-09 Profisil® Fluoride Varnish Normal pack, 50 x 0.5 ml Unflavored |