Primary Device ID | EKUR001024KA1 |
NIH Device Record Key | 1ced5dff-d361-485f-a14d-b8a03dca0fd8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Applicator brush (fine) |
Version Model Number | #1024-KA |
Company DUNS | 697119498 |
Company Name | KURARAY NORITAKE DENTAL INC. |
Device Count | 50 |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | EKUR001024KA0 [Unit of Use] |
HIBCC | EKUR001024KA1 [Primary] |
KXR | Applicator, 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 | 2024-09-03 |
Device Publish Date | 2024-08-26 |
EKUR1259680KA0 - KATANA™ Zirconia ONE | 2024-11-29 For IMPLANT S A1 |
EKUR1259681KA0 - KATANA™ Zirconia ONE | 2024-11-29 For IMPLANT S A2 |
EKUR1259682KA0 - KATANA™ Zirconia ONE | 2024-11-29 For IMPLANT S A3 |
EKUR1259683KA0 - KATANA™ Zirconia ONE | 2024-11-29 For IMPLANT S A3.5 |
EKUR1259684KA0 - KATANA™ Zirconia ONE | 2024-11-29 For IMPLANT S B1 |
EKUR1259685KA0 - KATANA™ Zirconia ONE | 2024-11-29 For IMPLANT S B2 |
EKUR1259686KA0 - KATANA™ Zirconia ONE | 2024-11-29 For IMPLANT S C1 |
EKUR1259687KA0 - KATANA™ Zirconia ONE | 2024-11-29 For IMPLANT S C2 |