N.A.
GUDID J0111631310000
"CONTEC lcr retainer / adhesive / Light-curing / For bonding retainers. "
DENTAURUM GmbH & Co.KG
Orthodontic bracket adhesive| Primary Device ID | J0111631310000 |
| NIH Device Record Key | 063f860b-8839-4de6-8cf1-ec5b274afcb8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N.A. |
| Version Model Number | 163-131-00 |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at 4-28°C/39-82°F/Protect from strong light or intense heat. Light sensitive. If room temp. exceeds 28°C/82 °F, store in refrigerator. Do not deep-freeze. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J0111631310000 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030644
FDA Product Code
| DYH | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-10 |
| Device Publish Date | 2019-04-02 |
On-Brand Devices [N.A.]
| J011724265510 | Ortho-Cast mini 22 Buccal tubes,0° Torque, 0° Offset for tooth 26-27/47-46 |
| J011724217510 | Ortho-Cast 22 Buccal tubes,- 20° Torque, 0° Offset for tooth 36-37 |
| J011602840550 | palex Medium - 10, angulated / RPE screw / For further information please visit our online-shop |
| J011602840310 | palex Medium - 10, angulated / RPE screw / For further information please visit our online-shop |
| J011602840110 | palex Medium - 10, abgewinkelt / RPE screw / For further information please visit our online-sho |
| J01123288000 | Ligator |
| J011026357000 | Plastic head with triangular hard metal tip (for molar band seater REF 026-354-00) |
| J0111631310000 | "CONTEC lcr retainer / adhesive / Light-curing / For bonding retainers. " |
| J0111631300000 | "CONTEC lcr assortment / adhesive / light-curing / For bonding of retainers " |
| J0111631150000 | "CONTEC etching gel / For etching dental enamel / Suitable for all CONTEC adhesives. " |
| J0111631131000 | CONTEC lc primer / adhesive / For CONTEC lc bracket adhesive (REF 163-111-00) and CONTEC lcr ret |
| J0111631110000 | "CONTEC lc bracket adhesive / Light-curing / for bonding metal brackets and buccal tubes, cerami |
| J0111631100000 | "CONTEC lc assortment / adhesive / Light-curing / For bonding metal brackets and buccal tubes, |
| J0111631001000 | CONTEC plastic primer / adhesive / for plastic brackets |
| J011724212510 | Ortho-Cast 22 Buccal tubes,- 14° Torque, 10° Offset for tooth 17-16 |
| J011724044000 | Ortho-Cast Buccal tubes 18, 0° Torque, 8° Offset for tooth 17-16/36-37 |
| J011320021000 | Bicuspids, 0.90 mm / 36 |
| J011023291000 | Srew for ligator (REF 023-288-00) |
| J011023290000 | Spool for ligator (REF 023-288-00) |
| J011023289000 | Hard metal tip for ligator (023-288-00) |
| J011724045000 | Ortho-Cast Buccal tubes 18, 0° Torque, 8° Offset for tooth 26-27/47-46 |
| J011745032000 | High-pull headgear without safety modules; pink cotton |
| J011724215000 | Ortho-Cast 22 Buccal tubes,- 14° Torque, 10° Offset for tooth 26-27 |
| J011724214000 | Ortho-Cast 22 Buccal tubes,- 14° Torque, 10° Offset for tooth 17-16 |
| J011822142200 | Ortho-Cast M-Series 22,-14°Torque,10°Offset,convertible, for tooth 26-27 |
| J011822142100 | Ortho-Cast M-Series 22,-14°Torque,10°Offset,convertible, for tooth 17-16 |
| J011822141200 | Ortho-Cast M-Series 22,-14°Torque,14°Offset,convertible, for tooth 26-27 |
| J011822141100 | Ortho-Cast M-Series 22,-14°Torque,14°Offset,convertible, for tooth 17-16 |
| J011818141200 | Ortho-Cast M-Series 18,-14°Torque,14°Offset,convertible, for tooth 26-27 |
| J011818141100 | Ortho-Cast M-Series 18,-14°Torque,14°Offset,convertible, for tooth 17-16 |
| J011607165000 | SUS³ set / Sabbagh Universal Spring / For further information please visit our online-shop on o |
| J011607160000 | SUS³ starter set / Sabbagh Universal Spring / For further information please visit our online-s |
| J011607159000 | SUS³ telescope rods / Sabbagh Universal Spring / For further information please visit our onlin |
| J011607158000 | SUS³ telescope rods, assembled / Sabbagh Universal Spring / For further information please visi |
| J011607157000 | SUS³ telescope element / Sabbagh Universal Spring / For further information please visit our on |
| J011607156000 | SUS³ turbo springs, length 27 mm / Sabbagh Universal Spring / For further information please vi |
| J011607154000 | SUS³ ball retainer clasps / Sabbagh Universal Spring / For further information please visit our |
| J011607153000 | SUS³ arch adapter/fixing screw / Sabbagh Universal Spring / For further information please visi |
| J011607152000 | SUS³ distance springs, length 10 mm / Sabbagh Universal Spring / For further information please |
| J011607151000 | SUS³ compression springs, length 15 mm / Sabbagh Universal Spring / For further information ple |
| J011724103000 | Ortho-Cast 22 Buccal tubes,0° Torque, 0° Offset for tooth 36-37 |
| J011724102000 | Ortho-Cast 22 Buccal tubes,0° Torque, 0° Offset for tooth 47-46 |
| J011607148000 | SUS² telescope rod, assembled / Sabbagh Universal Spring / For further information please visi |
| J011607146000 | SUS² turbo spring |
| J011724251510 | Ortho-Cast mini 18 Buccal tubes,- 14° Torque, 0° Offset for tooth 26-27 |
| J011724250510 | Ortho-Cast mini 18 Buccal tubes,- 14° Torque, 0° Offset for tooth 17-16 |
| J011607147000 | SUS² telescope element |
| J011728510010 | Titanium lingual retainer acc. to Kimmich, Length 30 mm |
| J011725034500 | Ortho Buccal tubes,6° Offset for tooth 26-27/47-46 |
| J011725033500 | Ortho Buccal tubes,6° Offset for tooth 17-16/36-37 |
Trademark Results [N.A.]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 N.A. 77965909 3968602 Live/Registered |
Okura USA, Inc. 2010-03-23 |
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