N.A.

GUDID J0111631001000

CONTEC plastic primer / adhesive / for plastic brackets

DENTAURUM GmbH & Co.KG

Orthodontic bracket adhesive
Primary Device IDJ0111631001000
NIH Device Record Keyd3d832c3-9367-4771-845a-3a5d6f2c313e
Commercial Distribution StatusIn Commercial Distribution
Brand NameN.A.
Version Model Number163-100-10
Company DUNS315427286
Company NameDENTAURUM GmbH & Co.KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)523-3946
Emailinfo@dentaurum-us.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 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 AgencyDevice ID
HIBCCJ0111631001000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-10
Device Publish Date2019-04-02

On-Brand Devices [N.A.]

J011724265510Ortho-Cast mini 22 Buccal tubes,0° Torque, 0° Offset for tooth 26-27/47-46
J011724217510Ortho-Cast 22 Buccal tubes,- 20° Torque, 0° Offset for tooth 36-37
J011602840550palex Medium - 10, angulated / RPE screw / For further information please visit our online-shop
J011602840310palex Medium - 10, angulated / RPE screw / For further information please visit our online-shop
J011602840110palex Medium - 10, abgewinkelt / RPE screw / For further information please visit our online-sho
J01123288000Ligator
J011026357000Plastic 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. "
J0111631131000CONTEC 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,
J0111631001000CONTEC plastic primer / adhesive / for plastic brackets
J011724212510Ortho-Cast 22 Buccal tubes,- 14° Torque, 10° Offset for tooth 17-16
J011724044000Ortho-Cast Buccal tubes 18, 0° Torque, 8° Offset for tooth 17-16/36-37
J011320021000Bicuspids, 0.90 mm / 36
J011023291000Srew for ligator (REF 023-288-00)
J011023290000Spool for ligator (REF 023-288-00)
J011023289000Hard metal tip for ligator (023-288-00)
J011724045000Ortho-Cast Buccal tubes 18, 0° Torque, 8° Offset for tooth 26-27/47-46
J011745032000High-pull headgear without safety modules; pink cotton
J011724215000Ortho-Cast 22 Buccal tubes,- 14° Torque, 10° Offset for tooth 26-27
J011724214000Ortho-Cast 22 Buccal tubes,- 14° Torque, 10° Offset for tooth 17-16
J011822142200Ortho-Cast M-Series 22,-14°Torque,10°Offset,convertible, for tooth 26-27
J011822142100Ortho-Cast M-Series 22,-14°Torque,10°Offset,convertible, for tooth 17-16
J011822141200Ortho-Cast M-Series 22,-14°Torque,14°Offset,convertible, for tooth 26-27
J011822141100Ortho-Cast M-Series 22,-14°Torque,14°Offset,convertible, for tooth 17-16
J011818141200Ortho-Cast M-Series 18,-14°Torque,14°Offset,convertible, for tooth 26-27
J011818141100Ortho-Cast M-Series 18,-14°Torque,14°Offset,convertible, for tooth 17-16
J011607165000SUS³ set / Sabbagh Universal Spring / For further information please visit our online-shop on o
J011607160000SUS³ starter set / Sabbagh Universal Spring / For further information please visit our online-s
J011607159000SUS³ telescope rods / Sabbagh Universal Spring / For further information please visit our onlin
J011607158000SUS³ telescope rods, assembled / Sabbagh Universal Spring / For further information please visi
J011607157000SUS³ telescope element / Sabbagh Universal Spring / For further information please visit our on
J011607156000SUS³ turbo springs, length 27 mm / Sabbagh Universal Spring / For further information please vi
J011607154000SUS³ ball retainer clasps / Sabbagh Universal Spring / For further information please visit our
J011607153000SUS³ arch adapter/fixing screw / Sabbagh Universal Spring / For further information please visi
J011607152000SUS³ distance springs, length 10 mm / Sabbagh Universal Spring / For further information please
J011607151000SUS³ compression springs, length 15 mm / Sabbagh Universal Spring / For further information ple
J011724103000Ortho-Cast 22 Buccal tubes,0° Torque, 0° Offset for tooth 36-37
J011724102000Ortho-Cast 22 Buccal tubes,0° Torque, 0° Offset for tooth 47-46
J011607148000SUS² telescope rod, assembled / Sabbagh Universal Spring / For further information please visi
J011607146000SUS² turbo spring
J011724251510Ortho-Cast mini 18 Buccal tubes,- 14° Torque, 0° Offset for tooth 26-27
J011724250510Ortho-Cast mini 18 Buccal tubes,- 14° Torque, 0° Offset for tooth 17-16
J011607147000SUS² telescope element
J011728510010Titanium lingual retainer acc. to Kimmich, Length 30 mm
J011725034500Ortho Buccal tubes,6° Offset for tooth 26-27/47-46
J011725033500Ortho Buccal tubes,6° Offset for tooth 17-16/36-37

Trademark Results [N.A.]

Mark Image

Registration | Serial
Company
Trademark
Application Date
N.A.
N.A.
77965909 3968602 Live/Registered
Okura USA, Inc.
2010-03-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.