FDA.report

Phoenix Optimal Maxx

Primary DI
05060772898941
Brand
Phoenix Optimal Maxx
Company
PHOENIX ORTHODONTICS INC
Model
D-800XX2-231B
Catalog number
D-800XX2-231B
Device description
OPTIMAL MAXX .022 BOND SGL NON TAPER NON CONVERT BUC TUBE UR LL 6 -10T 0DO PK10
Published
2020-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZDTUBE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060772898934PrimaryGS10
05060772898941Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060772898934050607728989345060772898934
05060772898941050607728989415060772898941

GMDN Terms

TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800) 642-3009sales@phoenixorthodontics.com
+18162286594sales@phoenixorthodontics.com
+18162286628kim@phoenixorthodontics.com

Regulatory Flags

DUNS number
002092976
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05060772890051Phoenix Elastic AttachersAX-ELA-MIXAX-ELA-MIX2020-08-17
05060772890068OrthoGap Archwire MarkersAX-WOMOGAX-WOMOG2020-08-17
05060772890075Phoenix Composite ButtonsC-CB-1021-BC-CB-1021-B2020-08-17
05060772890082Phoenix Composite ButtonsC-CB-504-BC-CB-504-B2020-08-17
05060772890099Phoenix OptimalD-80010-237BD-80010-237B2020-08-17
05060772890112Phoenix OptimalD-80010-238BD-80010-238B2020-08-17
05060772890136Phoenix OptimalD-80010-245BD-80010-245B2020-08-17
05060772890150Phoenix OptimalD-80010-246BD-80010-246B2020-08-17
05060772890174Phoenix Optimal 2XD-8012X10-235BD-8012X10-235B2020-08-17
05060772890198Phoenix Optimal 2XD-8012X10-236BD-8012X10-236B2020-08-17
05060772890211Phoenix Optimal 2XD-8012X10-255BD-8012X10-255B2020-08-17
05060772890235Phoenix Optimal 2XD-8012X10-256BD-8012X10-256B2020-08-17
05060772890259Phoenix Bondable ButtonD-BB-RCD-BB-RC2020-08-17
05060772890273Phoenix Bondable ButtonD-BBR-MFD-BBR-MF2020-08-17
05060772890297Phoenix Buccal TubeD-CS1B10-205ED-CS1B10-205E2020-08-17
05060772890310Phoenix Buccal TubeD-CS1B10-206ED-CS1B10-206E2020-08-17
05060772890334Phoenix Buccal TubeD-CS1B10-207ED-CS1B10-207E2020-08-17
05060772890358Phoenix Buccal TubeD-CS1B10-208ED-CS1B10-208E2020-08-17
05060772890372Phoenix Buccal TubeD-CS1B10-215ED-CS1B10-215E2020-08-17
05060772890396Phoenix Buccal TubeD-CS1B10-216ED-CS1B10-216E2020-08-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07908611204158ICERAM CERAMIC BUTTON FOR BONDING - 2UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611204172ICERAM CERAMIC BUTTON FOR BONDING - 10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207715BONDING TUBE MJANSON MBT 0,022 -SINGLE/N CONVERTIBLE U67R (16/17) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207722MINI BONDING TUBE MJANSON MBT 0.022 – SINGLE / N CONVERTIBLE U7R (17) -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207739BONDING TUBE MJANSON MBT 0,022 - SINGLE/N CONVERTIBLE U67L (26/27) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207746MINI BONDING TUBE MJANSON MBT 0.022 – SINGLE / N CONVERTIBLE U7L (27) -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207753BONDING TUBE MJANSON MBT 0,022 - SINGLE/N CONVERTIBLE L67L (36/37) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207760MINI BONDING TUBE MJANSON MBT 0.022 – SINGLE / N CONVERTIBLE L7L (37) -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207777BONDING TUBE MJANSON MBT 0,022 - SINGLE/N CONVERTIBLE L67R (46/47) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207784MINI BONDING TUBE MJANSON MBT 0.022 – SINGLE / N CONVERTIBLE L7R (47) -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207791BONDING TUBE MJANSON MBT 0,022 - SINGLE/CONVERTIBLE U6R (16) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207807BONDING TUBE MJANSON MBT 0,022 - SINGLE/CONVERTIBLE U6L (26) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207814BONDING TUBE MJANSON MBT 0,022 - SINGLE/CONVERTIBLE L6L (36) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207821BONDING TUBE MJANSON MBT 0,022 - SINGLE/CONVERTIBLE L6R (46) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207838MINI TUBE UNIVERSAL MJANSON MBT 0.022 - BONDING - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207999KIT BONDING TUBES ADVANCED MBT 0.022 - 200UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
00190746197116Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197123Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197130Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197147Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197154Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197161Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197178Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197185Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197192Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197208Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197215Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197222Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197239Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197246Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23