Dentalastics®
GUDID J011774000000
Dentalastics® rotation wedges, transparent
DENTAURUM GmbH & Co.KG
Orthodontic archwire/bracket ligature| Primary Device ID | J011774000000 |
| NIH Device Record Key | 8faf828c-491f-44b7-ab8f-5bdc62014cf1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dentalastics® |
| Version Model Number | 774-000-00 |
| Company DUNS | 315427286 |
| Company Name | DENTAURUM GmbH & Co.KG |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | |
| 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 | |
| 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 |
| 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 | J011774000000 [Primary] |
| HIBCC | J011774000001 [Unit of Use] |
FDA Product Code
| ECI | BAND, ELASTIC, 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 | 3 |
| Public Version Date | 2021-06-22 |
| Device Publish Date | 2016-09-15 |
On-Brand Devices [Dentalastics®]
| J011774551000 | Dentalastics® personal plastic ligatures, transparent |
| J011774561010 | Dentalastics® personal colored plastic ligatures/Assortment/ For further information please vis |
| J011774003000 | Dentalastics® rotation wedges, grey |
| J011774563000 | Dentalastics® personal plastic ligatures, pearl |
| J011774560000 | Dentalastics® personal plastic ligatures, orange |
| J011774559000 | Dentalastics® personal plastic ligatures, green |
| J011774558000 | Dentalastics® personal plastic ligatures, yellow |
| J011774557000 | Dentalastics® personal plastic ligatures, purple |
| J011774556000 | Dentalastics® personal plastic ligatures, red |
| J011774555000 | Dentalastics® personal plastic ligatures, blue |
| J011774554000 | Dentalastics® personal plastic ligatures, pink |
| J011774553000 | Dentalastics® personal plastic ligatures, white |
| J011774552000 | Dentalastics® personal plastic ligatures, black |
| J011774551021 | Dentalastics® Personal ligatures, transparent |
| J011774549000 | Dentalastics® personal plastic ligatures, silver |
| J011774300000 | Dentalastics® extraoral plastic chain |
| J011774200010 | Dentalastics® separators, blue |
| J011774102010 | Dentalastics® plastic ligatures with short connector, Length 6.6 mm |
| J011774100010 | Dentalastics® separators, green |
| J011774002010 | Dentalastics® plastic ligatures, transparent |
| J011774000000 | Dentalastics® rotation wedges, transparent |
| J011774549011 | Dentalastics® Personal ligatures, silver |
| J011774555011 | Dentalastics® Personal ligatures, blue |
| J011774554011 | Dentalastics® Personal ligatures, pink |
| J011774558011 | Dentalastics® Personal plastic ligatures, yellow |
Trademark Results [Dentalastics]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DENTALASTICS 79035505 3312964 Live/Registered |
DENTAURUM GmbH & Co. KG 2007-02-02 |
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