FDA.reportPublic FDA data

Phoenix Stainless Steel

Primary DI
05060779991225
Brand
Phoenix Stainless Steel
Company
PHOENIX ORTHODONTICS INC
Model
S-1B67-UR305
Catalog number
S-1B67-UR305
Device description
OPT 1 MOLAR BAND UP RIGHT 6/7 SIZE 30.5 PK5
Published
2020-08-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
05060779991225PrimaryGS10
05060779991232Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060779991225050607799912255060779991225
05060779991232050607799912325060779991232

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.

Contacts#

Phone, Email table
PhoneEmail
+18162286628kim@phoenixorthodontics.com

Regulatory Flags#

DUNS number
002092976
Device count
5
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
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
05060772890389Phoenix Buccal TubeD-CS1B10-216ED-CS1B10-216E2020-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033707035763LEONE SPALEONE SPAECM2020-11-11
08033707035770LEONE SPALEONE SPAECM2020-11-11
08033707035787LEONE SPALEONE SPAECM2020-11-11
08033707035794LEONE SPALEONE SPAECM2020-11-11
08033707035800LEONE SPALEONE SPAECM2020-11-11
08033707035817LEONE SPALEONE SPAECM2020-11-11
08033707035824LEONE SPALEONE SPAECM2020-11-11
08033707035831LEONE SPALEONE SPAECM2020-11-11
08033707035848LEONE SPALEONE SPAECM2020-11-11
08033707035855LEONE SPALEONE SPAECM2020-11-11
08033707035862LEONE SPALEONE SPAECM2020-11-11
08033707035879LEONE SPALEONE SPAECM2020-11-11
08033707035886LEONE SPALEONE SPAECM2020-11-11
08033707035893LEONE SPALEONE SPAECM2020-11-11
08033707035909LEONE SPALEONE SPAECM2020-11-11
08033707035916LEONE SPALEONE SPAECM2020-11-11
08033707035923LEONE SPALEONE SPAECM2020-11-11
08033707035930LEONE SPALEONE SPAECM2020-11-11
08033707035947LEONE SPALEONE SPAECM2020-11-11
08033707035954LEONE SPALEONE SPAECM2020-11-11
08033707035961LEONE SPALEONE SPAECM2020-11-11
08033707035978LEONE SPALEONE SPAECM2020-11-11
08033707035985LEONE SPALEONE SPAECM2020-11-11
08033707035992LEONE SPALEONE SPAECM2020-11-11
08033707036005LEONE SPALEONE SPAECM2020-11-11
08033707036012LEONE SPALEONE SPAECM2020-11-11
08033707036029LEONE SPALEONE SPAECM2020-11-11
08033707036036LEONE SPALEONE SPAECM2020-11-11
08033707036043LEONE SPALEONE SPAECM2020-11-11
08033707036050LEONE SPALEONE SPAECM2020-11-11