rematitan®
GUDID J011766278000
rematitan® sl ideal arches, rectangular, with dimple Maxillary, 0.41 x 0.41 mm / 16 x 16
DENTAURUM GmbH & Co.KG
Orthodontic archwire| Primary Device ID | J011766278000 |
| NIH Device Record Key | a30ece4b-04ca-411c-b0b6-d0bf4c0d8d3b |
| Commercial Distribution Discontinuation | 2024-06-19 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | rematitan® |
| Version Model Number | 766-278-00 |
| 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 |
| 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 *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 | J011766278000 [Primary] |
| HIBCC | J011766278001 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-06-19 |
| Device Publish Date | 2016-09-15 |
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 |
Trademark Results [rematitan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REMATITAN 77288395 3694579 Live/Registered |
DENTAURUM GMBH & CO. KG 2007-09-25 |
 REMATITAN 73562862 1424542 Dead/Cancelled |
DENTAURUM J.P. WINKELSTROETER KG 1985-10-11 |
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