FDA.reportPublic FDA data

Phoenix Stainless Steel

Primary DI
05060779992437
Brand
Phoenix Stainless Steel
Company
PHOENIX ORTHODONTICS INC
Model
S-1B6-LR305
Catalog number
S-1B6-LR305
Device description
OPT 1 MOLAR BAND LOW RIGHT 6 SIZE 30.5 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
05060779992420PrimaryGS10
05060779992437Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060779992420050607799924205060779992420
05060779992437050607799924375060779992437

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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840018667815Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECM2025-11-06
10190707120051TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120068TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120075TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120082TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120099TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120105TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120112TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120129TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120136TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120143TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120150TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120167TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120174TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120181TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120198TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120204TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120211TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120228TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120235TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120242TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120259TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120266TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120273TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120280TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120297TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120303TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120310TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120327TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120334TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17