| Primary Device ID | D8095021 |
| NIH Device Record Key | f5057a9b-3edc-4aab-80b3-59dcd41200ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Roydent |
| Version Model Number | 502 |
| Catalog Number | 502 |
| 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 | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com | |
| Phone | +1(800)992-7767 |
| info@roydent.com |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| Weight | 74 Gram |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | D8095021 [Primary] |
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN |
| 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) |