FDA.reportPublic FDA data

Pg Supply

Primary DI
05056389639121
Brand
Pg Supply
Company
Pg Supply, Inc.
Model
NSDOPT-108
Catalog number
NSDOPT-108
Device description
Niti SE Optima Dimpled .018
Published
2025-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
05056389639121PrimaryGS10
05056389639343Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056389639121050563896391215056389639121
05056389639343050563896393435056389639343

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic wireA thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
+1(860) 673-4155debbie@pgsupply.com

Regulatory Flags#

DUNS number
798685988
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056389639060Pg SupplyNSDOPT-102NSDOPT-1022025-10-13
05056389639077Pg SupplyNSDOPT-102rNSDOPT-102r2025-10-13
05056389639084Pg SupplyNSDOPT-104NSDOPT-1042025-10-13
05056389639091Pg SupplyNSDOPT-104rNSDOPT-104r2025-10-13
05056389639107Pg SupplyNSDOPT-106NSDOPT-1062025-10-13
05056389639114Pg SupplyNSDOPT-106rNSDOPT-106r2025-10-13
05056389639138Pg SupplyNSDOPT-108rNSDOPT-108r2025-10-13
05056389639145Pg SupplyNSDOPT-110NSDOPT-1102025-10-13
05056389639152Pg SupplyNSDOPT-110rNSDOPT-110r2025-10-13
05056389639169Pg SupplyNSDOPT-112NSDOPT-1122025-10-13
05056389639176Pg SupplyNSDOPT-112rNSDOPT-112r2025-10-13
05056389639183Pg SupplyNSDOPT-114NSDOPT-1142025-10-13
05056389639190Pg SupplyNSDOPT-114rNSDOPT-114r2025-10-13
05056389639206Pg SupplyNSDOPT-116NSDOPT-1162025-10-13
05056389639213Pg SupplyNSDOPT-116rNSDOPT-116r2025-10-13
05056389639220Pg SupplyNSDOPT-118NSDOPT-1182025-10-13
05056389639237Pg SupplyNSDOPT-118rNSDOPT-118r2025-10-13
05056389639244Pg SupplyNSDOPT-120NSDOPT-1202025-10-13
05056389639251Pg SupplyNSDOPT-120rNSDOPT-120r2025-10-13
05056389639268Pg SupplyNSDOPT-122NSDOPT-1222025-10-13

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