Primary Device ID | D809205STD1 |
NIH Device Record Key | dd93da85-39b6-454e-8c63-eaaeab8eb0a1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Roydent |
Version Model Number | 205STD |
Catalog Number | 205STD |
Company DUNS | 131487225 |
Company Name | ROYDENT DENTAL PRODUCTS INC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 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 |
Phone | +1(800)992-7767 |
info@roydent.com | |
Phone | +1(800)992-7767 |
info@roydent.com |
Total Volume | 6 Milliliter |
Total Volume | 6 Milliliter |
Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D809205STD1 [Primary] |
EMA | CEMENT, DENTAL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-10-07 |
D809PL2091 | ENDO-CLEANSE 8oz. BOTTLE |
D809PL2081 | ENDO CLEANSE 2oz. BOTTLE |
D8097651 | BULK TO DYE FOR BLUE 150CT |
D8097601 | TO DYE FOR |
D8097091 | CHEMLOCK MINI KIT |
D8097031 | EDTA (28 PKG) |
D8097021 | CHEMLOCK BONDING ENHANCER |
D8097011 | CHEMLOCK CEMENT |
D8095031 | REFORM TEMP. C&B MATERIAL B1 |
D8095021 | REFORM TEMP. C&B MATERIAL A3.5 |
D8095011 | REFORM TEMP. C&B MATERIAL A2 |
D8095001 | REFORM TEMP. C&B MATERIAL A1 |
D809205STD1 | BOSTON POSTS CEMENT STD. |
D8091031 | C.L. CANAL LUBRICANT (20 COUNT |
D809102502R1 | 2Seal Easymix Tips Refill |
D809102501R1 | 2Seal Easymix Syringe Refill |
D8091011 | C.L. CANAL LUBRICANT (150) |