FDA.report

Phoenix Nickel Titanium

Primary DI
05060772898620
Brand
Phoenix Nickel Titanium
Company
PHOENIX ORTHODONTICS INC
Model
N-SYM-1622L
Catalog number
N-SYM-1622L
Device description
SYMMETRY NT .016X.022 LOWER 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

Related Records

Contact Domains

Product Codes

CodeName
DZCWIRE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060772898613PrimaryGS10
05060772898620Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060772898613050607728986135060772898613
05060772898620050607728986205060772898620

GMDN Terms

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.

Device Sizes

TypeValueUnit
Height0.016Inch
Width0.022Inch

Sterilization Methods

Method

Contacts

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 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

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