rematitan®

GUDID J011766018000

rematitan® "LITE" Spee, upper, 0.35 mm/14

DENTAURUM GmbH & Co.KG

Orthodontic archwire

• Primary Device ID: J011766018000
• NIH Device Record Key: f0082436-e442-4e68-b6db-182d833f035d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rematitan®
• Version Model Number: 766-018-00
• Company DUNS: 315427286
• Company Name: DENTAURUM GmbH & Co.KG
• Device Count: 10
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J011766018000 [Primary]
HIBCC	J011766018001 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935140

FDA Product Code

• DZC: WIRE, ORTHODONTIC

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: 2019-09-26
• Device Publish Date: 2019-09-18

On-Brand Devices [rematitan®]

• J011766018000: rematitan® "LITE" Spee, upper, 0.35 mm/14
• J011210012000: rematitan® bar sleeve macro + retention
• J011600400300: Expansion screw, Titanium, Medium/ For further information please visit our online-shop on our w
• J011600400100: Expansion screw, Titanium, Medium / For further information please visit our online-shop on our
• J011210022000: rematitan® bar sleeve micro + retention
• J011210021000: rematitan®bar attachment mirco, 40 x 1.6 x 2.3 mm
• J011210020000: rematitan® bar hinge micro, 40 x 1.6 x 2.25 mm
• J011210011000: rematitan® bar attachment macro, 40 x 2.1 x 3.0 mm
• J011210010000: rematitan® bar hinge macro, 40 x 2.1 x 3.0 mm
• J011766277000: rematitan® sl ideal arches, round, with dimple Mandibular, 0.45 mm / 18
• J011100130870: rematitan® CL
• J011766276000: rematitan® sl ideal arches, round, with dimple Maxillary, 0.45 mm / 18
• J011100205300: rematitan® milling blank Ti5 30 mm
• J011100205250: rematitan® milling blank Ti5 25 mm
• J011100145870: PL rematitan® powder 15 - 45 µm
• J011100145000: rematitan® powder 15 - 45 µm
• J011766275000: rematitan® sl ideal arches, round, with dimple Mandibular, 0.40 mm / 16
• J011100205200: rematitan® milling blank Ti5 20 mm
• J011100205150: rematitan® milling blank Ti5 15 mm
• J011100205120: rematitan® milling blank Ti5 12 mm
• J011100205100: rematitan® milling blank Ti5 10 mm
• J011100202200: rematitan® milling blank Ti2 20 mm
• J011100202150: rematitan® milling blank Ti2 15 mm
• J011100202120: rematitan® milling blank Ti2 12 mm
• J011100202100: rematitan® milling blank Ti2 10 mm
• J011766285000: rematitan® sl ideal arches, rectangular, with dimple Mandibular, 0.48 x 0.64 mm / 19 x 25
• J011766284000: rematitan® sl ideal arches, rectangular, with dimple Maxillary, 0.48 x 0.64 mm / 19 x 25
• J011766282000: rematitan® sl ideal arches, rectangular, with dimple Maxillary, 0.43 x 0.64 mm / 17 x 25
• J011766281000: rematitan® sl ideal arches, rectangular, with dimple Mandibular, 0.41 x 0.56 mm / 16 x 22
• J011766280000: rematitan® sl ideal arches, rectangular, with dimple Maxillary, 0.41 x 0.56 mm / 16 x 22
• J011766279000: rematitan® sl ideal arches, rectangular, with dimple Mandibular, 0.41 x 0.41 mm / 16 x 16
• J011766278000: rematitan® sl ideal arches, rectangular, with dimple Maxillary, 0.41 x 0.41 mm / 16 x 16
• J011766274000: rematitan® sl ideal arches, round, with dimple Maxillary, 0.40 mm / 16
• J011766273000: rematitan® sl ideal arches, round, with dimple Mandibular, 0.35 mm / 14
• J011766272000: rematitan® sl ideal arches, round, with dimple Maxillary, 0.35 mm / 14
• J011766271000: rematitan® sl ideal arches, round, with dimple Mandibular, 0.30 mm / 12
• J011766270000: rematitan® sl ideal arches, round, with dimple Maxillary, 0.30 mm / 12
• J011758364000: Rematian"LITE"open compr. springs,medium
• J011758363000: Rematitan "LITE" open compr. springs,low