N.A.

GUDID J011160100100

Novel design "Elephant"

DENTAURUM GmbH & Co.KG

Orthodontic appliance system, bonded

• Primary Device ID: J011160100100
• NIH Device Record Key: 29583892-d73b-4ff6-b439-d34ecb2a4625
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N.A.
• Version Model Number: 160-100-10
• Company DUNS: 315427286
• Company Name: DENTAURUM GmbH & Co.KG
• Device Count: 20
• 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: false
• 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
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J011160100100 [Primary]
HIBCC	J011160100101 [Unit of Use]

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: 2016-09-15

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