Primary Device ID | D661SBH82504500 |
NIH Device Record Key | 5bdfcd96-b5bb-4ec9-b1c8-3a7bca62f75c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HyFlex CM |
Version Model Number | SBH8250450 |
Company DUNS | 622185718 |
Company Name | COLTENE/WHALEDENT INC |
Device Count | 6 |
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 | false |
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 | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com | |
Phone | 3309168800 |
info@coltene.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D661SBH82504500 [Unit of Use] |
HIBCC | D661SBH82504501 [Primary] |
EKS | File, Pulp Canal, Endodontic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-30 |
Device Publish Date | 2023-06-22 |
D661SBHNT825SML0 | HYFLEX NT FILE ASST SMALL 25MM |
D661SBHNT825MED0 | HYFLEX NT FILE ASST MED 25MM |
D661SBHNT825LRG0 | HYFLEX NT FILE ASST LRG 25MM |
D661SBHNT82506400 | HYFLEX NT FILE 25MM 06/40 6PK |
D661SBHNT82506350 | HYFLEX NT FILE 25MM 06/35 6PK |
D661SBHNT82506300 | HYFLEX NT FILE 25MM 06/30 6PK |
D661SBHNT82506250 | HYFLEX NT FILE 25MM 06/25 6PK |
D661SBHNT82506200 | HYFLEX NT FILE 25MM 06/20 6PK |
D661SBHNT82504600 | HYFLEX NT FILE 25MM 04/60 6PK |
D661SBHNT82504500 | HYFLEX NT FILE 25MM 04/50 6PK |
D661SBHNT82504450 | HYFLEX NT FILE 25MM 04/45 6PK |
D661SBHNT82504400 | HYFLEX NT FILE 25MM 04/40 6PK |
D661SBHNT82504350 | HYFLEX NT FILE 25MM 04/35 6PK |
D661SBHNT82504300 | HYFLEX NT FILE 25MM 04/30 6PK |
D661SBHNT82504250 | HYFLEX NT FILE 25MM 04/25 6PK |
D661SBHNT82504200 | HYFLEX NT FILE 25MM 04/20 6PK |
D661SBHNT82504150 | HYFLEX NT FILE 25MM 04/15 6PK |
D661SBHNT821SML0 | HYFLEX NT FILE ASST SMALL 21MM |
D661SBHNT821MED0 | HYFLEX NT FILE ASST MED 21MM |
D661SBHNT821LRG0 | HYFLEX NT FILE ASST LRG 21MM |
D661SBHNT82106400 | HYFLEX NT FILE 21MM 06/40 6PK |
D661SBHNT82106350 | HYFLEX NT FILE 21MM 06/35 6PK |
D661SBHNT82106300 | HYFLEX NT FILE 21MM 06/30 6PK |
D661SBHNT82106250 | HYFLEX NT FILE 21MM 06/25 6PK |
D661SBHNT82106200 | HYFLEX NT FILE 21MM 06/20 6PK |
D661SBHNT82104600 | HYFLEX NT FILE 21MM 04/60 6PK |
D661SBHNT82104500 | HYFLEX NT FILE 21MM 04/50 6PK |
D661SBHNT82104450 | HYFLEX NT FILE 21MM 04/45 6PK |
D661SBHNT82104400 | HYFLEX NT FILE 21MM 04/40 6PK |
D661SBHNT82104350 | HYFLEX NT FILE 21MM 04/35 6PK |
D661SBHNT82104300 | HYFLEX NT FILE 21MM 04/30 6PK |
D661SBHNT82104250 | HYFLEX NT FILE 21MM 04/25 6PK |
D661SBHNT82104200 | HYFLEX NT FILE 21MM 04/20 6PK |
D661SBHNT82104150 | HYFLEX NT FILE 21MM 04/15 6PK |
D661SBHGPF831ASST0 | GLIDEPATH FILE ASST 31 MM |
D661SBHGPF83120020 | GPF CMK 20/02 X 31MM FILE 6PK |
D661SBHGPF83115020 | GPF CMK 15/02 X 31MM FILE 6PK |
D661SBHGPF83115010 | GPF NAV 15/01 X 31MM FILE 6PK |
D661SBHGPF825ASST0 | GLIDEPATH FILE ASST 25 MM |
D661SBHGPF82520020 | GPF CMK 20/02 X 25MM FILE 6PK |
D661SBHGPF82515020 | GPF CMK 15/02 X 25MM FILE 6PK |
D661SBHGPF82515010 | GPF NAV 15/01 X 25MM FILE 6PK |
D661SBHGPF821ASST0 | GLIDEPATH FILE ASST 21 MM |
D661SBHGPF82120020 | GPF CMK 20/02 X 21MM FILE 6PK |
D661SBHGPF82115020 | GPF CMK 15/02 X 21MM FILE 6PK |
D661SBHGPF82115010 | GPF NAV 15/01 X 21MM FILE 6PK |
D661SBH831SML0 | HYFLEX CM FILE ASST SML 31MM |
D661SBH831MED0 | HYFLEX CM FILE ASST MED 31MM |
D661SBH831LRG0 | HYFLEX CM FILE ASST LRG 31MM |
D661SBH83106400 | HYFLEX CM FILE 06/40 31MM 6PK |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HYFLEX CM 85301457 4152819 Live/Registered |
Coltene/Whaledent, Inc. 2011-04-21 |