FDA.reportPublic FDA data

OrthoGap Archwire Markers

Primary DI
05060772890068
Brand
OrthoGap Archwire Markers
Company
PHOENIX ORTHODONTICS INC
Model
AX-WOMOG
Catalog number
AX-WOMOG
Device description
ORTHOGAP ARCHWIRE MARKERS PK100
Published
2020-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060772890013PrimaryGS10
05060772890068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060772890013050607728900135060772890013
05060772890068050607728900685060772890068

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800) 642-3009sales@phoenixorthodontics.com
+1(816)228-6594sales@phoenixorthodontics.com
+1(816)2286628kim@phoenixorthodontics.com

Regulatory Flags#

DUNS number
002092976
Device count
100
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060772890365Phoenix Buccal TubeD-CS1B10-215ED-CS1B10-215E2020-08-17
05060772893748Phoenix Key TieE-T-KCORE-T-KCOR2020-08-17
05060779991225Phoenix Stainless SteelS-1B67-UR305S-1B67-UR3052020-08-17
05060779994363Phoenix Stainless SteelS-KT-012S-KT-0122020-08-17
05060779994462Phoenix Stainless SteelS-LT-011S-LT-0112020-08-17
05060779994486Phoenix Stainless SteelS-LT-012S-LT-0122020-08-17
05060772890044Phoenix OptimalD-80010-237BD-80010-237B2020-08-17
05060772890105Phoenix OptimalD-80010-238BD-80010-238B2020-08-17
05060772890129Phoenix OptimalD-80010-245BD-80010-245B2020-08-17
05060772890143Phoenix OptimalD-80010-246BD-80010-246B2020-08-17
05060772890167Phoenix Optimal 2XD-8012X10-235BD-8012X10-235B2020-08-17
05060772890181Phoenix Optimal 2XD-8012X10-236BD-8012X10-236B2020-08-17
05060772890204Phoenix Optimal 2XD-8012X10-255BD-8012X10-255B2020-08-17
05060772890228Phoenix Optimal 2XD-8012X10-256BD-8012X10-256B2020-08-17
05060772890242Phoenix Bondable ButtonD-BB-RCD-BB-RC2020-08-17
05060772890266Phoenix Bondable ButtonD-BBR-MFD-BBR-MF2020-08-17
05060772890280Phoenix Buccal TubeD-CS1B10-205ED-CS1B10-205E2020-08-17
05060772890303Phoenix Buccal TubeD-CS1B10-206ED-CS1B10-206E2020-08-17
05060772890327Phoenix Buccal TubeD-CS1B10-207ED-CS1B10-207E2020-08-17
05060772890341Phoenix Buccal TubeD-CS1B10-208ED-CS1B10-208E2020-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
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07908854000654Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
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07908854000678Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
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07908854000890Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
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07908854001071Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001163Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22