FDA.reportPublic FDA data

SmartArch

Primary DI
D948SAODROL00160
Brand
SmartArch
Company
Smarter Alloys Inc
Model
SAO-DROL-0016
Device description
"SmartArch .016"" (0.406mm) Round Damon Lower Orthodontic CuNiTi Archwire"
Published
2021-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZCWire, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D948SAODROL00161PackageHIBCC10In Commercial Distribution
D948SAODROL00160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
200106716
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D948PBXLGH251Paradigm QuantumLGHTPBX-LG-H252021-08-25
D948PBXMDH251Paradigm QuantumMDHTPBX-MD-H252021-08-25
D948PBXPRH251Paradigm QuantumPRHTPBX-PR-H252021-08-25
D948PBXSMH251Paradigm QuantumSMHTPBX-SM-H252021-08-25
D948PBXLGH250Paradigm QuantumLGHTPBX-LG-H252021-08-25
D948PBXMDH250Paradigm QuantumMDHTPBX-MD-H252021-08-25
D948PBXPRH250Paradigm QuantumPRHTPBX-PR-H252021-08-25
D948PBXSMH250Paradigm QuantumSMHTPBX-SM-H252021-08-25
D948SAODREL18250SmartArchSAO-DREL-18252021-04-05
D948SAODREU18250SmartArchSAO-DREU-18252021-04-05
D948SAODREL18251SmartArchSAO-DREL-18252021-04-05
D948SAODREU18251SmartArchSAO-DREU-18252021-04-05
D948SAODROL00161SmartArchSAO-DROL-00162021-04-05
D948SAODROU00160SmartArchSAO-DROU-00162021-04-05
D948PBXLGN251Paradigm QuantumLGPBX-LG-N252020-11-04
D948PBXMDN251Paradigm QuantumMDPBX-MD-N252020-11-04
D948PBXPRN251Paradigm QuantumPRPBX-PR-N252020-11-04
D948PBXSMN251Paradigm QuantumSMPBX-SM-N252020-11-04
D948PBXA1N251Paradigm BXA1PBX-A1-N252020-05-21
D948PBXA2N251Paradigm BXA2PBX-A2-N252020-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456209882JMUJMU DENTAL, INCDZC2026-06-25
00840456209899JMUJMU DENTAL, INCDZC2026-06-25
00840456209905JMUJMU DENTAL, INCDZC2026-06-25
00840456209912JMUJMU DENTAL, INCDZC2026-06-25
00840456209929JMUJMU DENTAL, INCDZC2026-06-25
00840456209936JMUJMU DENTAL, INCDZC2026-06-25
00840456209943JMUJMU DENTAL, INCDZC2026-06-25
00840456209950JMUJMU DENTAL, INCDZC2026-06-25
00840456209967JMUJMU DENTAL, INCDZC2026-06-25
00840456209974JMUJMU DENTAL, INCDZC2026-06-25
00840456209981JMUJMU DENTAL, INCDZC2026-06-25
00840456209998JMUJMU DENTAL, INCDZC2026-06-25
00840456210000JMUJMU DENTAL, INCDZC2026-06-25
00840456210017JMUJMU DENTAL, INCDZC2026-06-25
00840456210024JMUJMU DENTAL, INCDZC2026-06-25
00840456210031JMUJMU DENTAL, INCDZC2026-06-25
00840456210048JMUJMU DENTAL, INCDZC2026-06-25
00840456210055JMUJMU DENTAL, INCDZC2026-06-25
00840456210062JMUJMU DENTAL, INCDZC2026-06-25
00840456210079JMUJMU DENTAL, INCDZC2026-06-25
00840456210086JMUJMU DENTAL, INCDZC2026-06-25
00840456210093JMUJMU DENTAL, INCDZC2026-06-25
00840456210109JMUJMU DENTAL, INCDZC2026-06-25
00840456210116JMUJMU DENTAL, INCDZC2026-06-25
00840456210123JMUJMU DENTAL, INCDZC2026-06-25
00840456210130JMUJMU DENTAL, INCDZC2026-06-25
00840456211182JMUJMU DENTAL, INCDZC2026-06-25
00840456211199JMUJMU DENTAL, INCDZC2026-06-25
00840456211205JMUJMU DENTAL, INCDZC2026-06-25
00840456211212JMUJMU DENTAL, INCDZC2026-06-25