Orthocryl®
GUDID J011161136000
Orthocryl® liquid, neon orange / orthodontic acrylics
DENTAURUM GmbH & Co.KG
Orthodontic appliance system, bonded| Primary Device ID | J011161136000 |
| NIH Device Record Key | 8a1fc75b-fa17-43bf-88f1-e86cf582909c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orthocryl® |
| Version Model Number | 161-136-00 |
| Company DUNS | 315427286 |
| Company Name | DENTAURUM GmbH & Co.KG |
| 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 | 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 |
Customer Support Contacts
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com | |
| Phone | +1(800)523-3946 |
| info@dentaurum-us.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a closed bottle / Protect from contamination and sunlight as they may cause premature polymerisation. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J011161136000 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K942667
FDA Product Code
| KMY | POSITIONER, TOOTH, PREFORMED |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2017-03-25 |
On-Brand Devices [Orthocryl®]
| J011161139000 | Orthocryl® liquid, neon blue |
| J011161912000 | Orthocryl® assortment, clear / orthodontic acrylics / For further information please visit our |
| J011161622000 | Orthocryl® Color concentrate, blue/ orthodontic acrylics |
| J011161620000 | Orthocryl® Color concentrate, red/ orthodontic acrylics |
| J011161611000 | Orthocryl® Disco glitter, mother of pearl |
| J011161609000 | Orthocryl® Disco glitter, gold |
| J011161608000 | Orthocryl® Disco glitter, silver |
| J011161607000 | Orthocryl® Disco glitter, blue |
| J011161606000 | Orthocryl® Disco glitter, red |
| J011161605000 | Orthocryl® Disco glitter, iris |
| J011161350000 | Orthocryl® liquid, transparent pink/ orthodontic acrylics |
| J011161300000 | Orthocryl® liquid, transparent pink/ orthodontic acrylics |
| J011161229000 | Orthocryl® liquid "Somno blue" |
| J011161227000 | Orthocryl® liquid "Somno pink" |
| J011161150000 | Orthocryl® liquid, clear/ orthodontic acrylics |
| J011161138000 | Orthocryl® liquid, neon green / orthodontic acrylics |
| J011161137000 | Orthocryl® liquid, neon pink / orthodontic acrylics |
| J011161136000 | Orthocryl® liquid, neon orange / orthodontic acrylics |
| J011161135000 | Orthocryl® liquid, neon yellow / orthodontic acrylics |
| J011161134000 | Orthocryl® liquid, violet / orthodontic acrylics |
| J011161133000 | Orthocryl® liquid, emerald green / orthodontic acrylics |
| J011161132000 | Orthocryl® liquid, hot pink / orthodontic acrylics |
| J011161131000 | Orthocryl® liquid, turquois/ orthodontic acrylics |
| J011161130000 | Orthocryl® liquid, yellow/ orthodontic acrylics |
| J011161129000 | Orthocryl® liquid, blue/ orthodontic acrylics |
| J011161128000 | Orthocryl® liquid, green/ orthodontic acrylics |
| J011161127000 | Orthocryl® liquid, red/ orthodontic acrylics |
| J011161100000 | Orthocryl® liquid, clear/ orthodontic acrylics |
| J011160700000 | Orthocryl® assortment, neon colors / orthodontic acrylics / For further information please visi |
| J011160600000 | Orthocryl®assortm."Multicolored palette" / orthodontic acrylics / For further information pleas |
| J011160502000 | Orthocryl® Small pack, clear/ orthodontic acrylics |
| J011160501000 | Orthocryl® Small pack, transparent pink/ orthodontic acrylics |
| J011160410000 | Bite paste for Orthocryl® LC, transparent |
| J011160406000 | Orthocryl® LC, green/ orthodontic acrylics |
| J011160405000 | Orthocryl® LC, yellow/ orthodontic acrylics |
| J011160404000 | Orthocryl® LC, blue/ orthodontic acrylics |
| J011160403000 | Orthocryl® LC, red/ orthodontic acrylics |
| J011160402000 | Orthocryl® LC, transparent pink/ orthodontic acrylics |
| J011160401000 | Orthocryl® LC, clear/ orthodontic acrylics |
| J011160400200 | Orthocryl® LC Start-Set, clear / orthodontic acrylics / For further information please visit ou |
| J011160400000 | Orthocryl® LC Start-Set german / orthodontic acrylics / For further information please visit ou |
| J011160301000 | Orthocryl® EQ powder, clear/ orthodontic acrylics |
| J011160300000 | Orthocryl® EQ powder, clear/ orthodontic acrylics |
| J011160212000 | Orthocryl® powder, clear/ orthodontic acrylics |
| J011160112000 | Orthocryl® powder, clear/ orthodontic acrylics |
| J011160014000 | Orthocryl® white powder/ orthodontic acrylics |
| J011160013000 | Orthocryl® black powder/ orthodontic acrylics |
| J011160012000 | Orthocryl® white powder/ orthodontic acrylics |
| J011160011000 | Orthocryl® black powder/ orthodontic acrylics |
Trademark Results [Orthocryl]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOCRYL 77593145 3825857 Live/Registered |
DENTAURUM GMBH & CO. KG 2008-10-15 |
 ORTHOCRYL 72407471 1027656 Dead/Expired |
STRATFORD-COOKSON COMPANY 1971-11-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.