FDA.reportPublic FDA data

Phoenix Buccal Tube

Primary DI
05060772890297
Brand
Phoenix Buccal Tube
Company
PHOENIX ORTHODONTICS INC
Model
D-CS1B10-205E
Catalog number
D-CS1B10-205E
Device description
.022 LOW PRO BOND BUCCAL TUBE MBT-ROTH U R SGL CONVERT W EXT BASE -10T:8DO 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZDTUBE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060772890280PrimaryGS10
05060772890297Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060772890280050607728902805060772890280
05060772890297050607728902975060772890297

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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 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
00840456203514JMUJMU DENTAL, INCDZD2026-06-25
00840456203521JMUJMU DENTAL, INCDZD2026-06-25
00840456203538JMUJMU DENTAL, INCDZD2026-06-25
00840456203545JMUJMU DENTAL, INCDZD2026-06-25
00840456203552JMUJMU DENTAL, INCDZD2026-06-25
00840456205297JMUJMU DENTAL, INCDZD2026-06-25
00840456205303JMUJMU DENTAL, INCDZD2026-06-25
00840456205310JMUJMU DENTAL, INCDZD2026-06-25
00840456205327JMUJMU DENTAL, INCDZD2026-06-25
00840456205334JMUJMU DENTAL, INCDZD2026-06-25
00840456205341JMUJMU DENTAL, INCDZD2026-06-25
00840456205358JMUJMU DENTAL, INCDZD2026-06-25
00840456205365JMUJMU DENTAL, INCDZD2026-06-25
00840456205372JMUJMU DENTAL, INCDZD2026-06-25
00840456206034JMUJMU DENTAL, INCDZD2026-06-25
00840456206041JMUJMU DENTAL, INCDZD2026-06-25
00840456206058JMUJMU DENTAL, INCDZD2026-06-25
00840456206089JMUJMU DENTAL, INCDZD2026-06-25
00840456206096JMUJMU DENTAL, INCDZD2026-06-25
00840456206102JMUJMU DENTAL, INCDZD2026-06-25
00840456206119JMUJMU DENTAL, INCDZD2026-06-25
00840456206126JMUJMU DENTAL, INCDZD2026-06-25
00840456206133JMUJMU DENTAL, INCDZD2026-06-25
00840456206140JMUJMU DENTAL, INCDZD2026-06-25
00840456206157JMUJMU DENTAL, INCDZD2026-06-25
00840456206164JMUJMU DENTAL, INCDZD2026-06-25
00840456206171JMUJMU DENTAL, INCDZD2026-06-25
00840456206188JMUJMU DENTAL, INCDZD2026-06-25
00840456206195JMUJMU DENTAL, INCDZD2026-06-25
00840456206201JMUJMU DENTAL, INCDZD2026-06-25