FDA.reportPublic FDA data

Phoenix Stainless Steel

Primary DI
05060779993212
Brand
Phoenix Stainless Steel
Company
PHOENIX ORTHODONTICS INC
Model
S-1B6-LL35
Catalog number
S-1B6-LL35
Device description
OPT 1 MOLAR BAND LOW LEFT 6 SIZE 35 PK5
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
ECMBAND, PREFORMED, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060779993205PrimaryGS10
05060779993212Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060779993205050607799932055060779993205
05060779993212050607799932125060779993212

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. 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
+18162286594sales@phoenixorthodontics.com
+18162286628kim@phoenixorthodontics.com

Regulatory Flags#

DUNS number
002092976
Device count
5
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
00840456206225JMUJMU DENTAL, INCECM2026-06-25
00840456206232JMUJMU DENTAL, INCECM2026-06-25
08033707035015LEONE SPALEONE SPAECM2020-11-10
08033707035022LEONE SPALEONE SPAECM2020-11-10
08033707035039LEONE SPALEONE SPAECM2020-11-10
08033707035046LEONE SPALEONE SPAECM2020-11-10
08033707035053LEONE SPALEONE SPAECM2020-11-10
08033707035060LEONE SPALEONE SPAECM2020-11-10
08033707035077LEONE SPALEONE SPAECM2020-11-10
08033707035084LEONE SPALEONE SPAECM2020-11-10
08033707035091LEONE SPALEONE SPAECM2020-11-10
08033707035107LEONE SPALEONE SPAECM2020-11-10
08033707035114LEONE SPALEONE SPAECM2020-11-10
08033707035121LEONE SPALEONE SPAECM2020-11-10
08033707035138LEONE SPALEONE SPAECM2020-11-10
08033707035145LEONE SPALEONE SPAECM2020-11-10
08033707035152LEONE SPALEONE SPAECM2020-11-10
08033707035169LEONE SPALEONE SPAECM2020-11-10
08033707035176LEONE SPALEONE SPAECM2020-11-10
08033707035183LEONE SPALEONE SPAECM2020-11-10
08033707035190LEONE SPALEONE SPAECM2020-11-10
08033707035206LEONE SPALEONE SPAECM2020-11-10
08033707035213LEONE SPALEONE SPAECM2020-11-10
08033707035220LEONE SPALEONE SPAECM2020-11-10
08033707035237LEONE SPALEONE SPAECM2020-11-10
08033707035244LEONE SPALEONE SPAECM2020-11-10
08033707035251LEONE SPALEONE SPAECM2020-11-10
08033707035268LEONE SPALEONE SPAECM2020-11-10
08033707035275LEONE SPALEONE SPAECM2020-11-10
08033707035282LEONE SPALEONE SPAECM2020-11-10