FDA.reportPublic FDA data

OSE

Primary DI
00810042124882
Brand
OSE
Company
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
Model
0550-010
Device description
BIO-OPTIMA - 16 X 16 UPPER MULTI-FORCE THERMAL NITI ARCHWIRE
Published
2026-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00810042124882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810042124882008100421248828100421248820810042124882

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
077801124
Device count
1
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810042124875OSE8007-7772026-01-28
00810042124844OSEX009-0062025-11-26
00810042124851OSEX009-0072025-11-26
00810042124868OSEX009-0082025-11-26
00869843000239Depend-On0169-0002016-07-29
00869843000277OSE0167-0002016-07-29
00869843000291OSE 8oz. Orthodontic Etching Gel - Blue240M-L002018-06-13
00810042124745OSE0202-0072023-08-11
00810042124752OSE0202-0082023-08-11
00810042124769OSE0202-0092023-08-11
00810042124738OSE0580-0122023-07-20
00810042124547OSE0202-F2023-06-21
00810042124554OSE0202-G2023-06-21
00810042124561OSE0202-H2023-06-21
00810042124578OSE0202-J2023-06-21
00810042124585OSE0202-K2023-06-21
00810042124592OSE0202-W2023-06-21
00810042124608OSE0202-Y2023-06-21
00810042124639OSE0202-N2023-06-21
00810042124646OSE0202-P2023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190707195014Retainer WireOrtho Organizers, Inc.DZC2026-10-20
05056389639589Pg SupplyPg Supply, Inc.DZC2026-09-28
05056389639596Pg SupplyPg Supply, Inc.DZC2026-09-28
05056389639602Pg SupplyPg Supply, Inc.DZC2026-09-28
05056389639619Pg SupplyPg Supply, Inc.DZC2026-09-28
J011520120000Noninium®DENTAURUM GmbH & Co.KGDZC2026-09-04
00840456209363JMUJMU DENTAL, INCDZC2026-06-24
00840456209370JMUJMU DENTAL, INCDZC2026-06-24
00840456209387JMUJMU DENTAL, INCDZC2026-06-24
00840456209394JMUJMU DENTAL, INCDZC2026-06-24
00840456209400JMUJMU DENTAL, INCDZC2026-06-24
00840456209417JMUJMU DENTAL, INCDZC2026-06-24
00840456209424JMUJMU DENTAL, INCDZC2026-06-24
00840456209431JMUJMU DENTAL, INCDZC2026-06-24
00840456209448JMUJMU DENTAL, INCDZC2026-06-24
00840456209455JMUJMU DENTAL, INCDZC2026-06-24
00840456209462JMUJMU DENTAL, INCDZC2026-06-24
00840456209479JMUJMU DENTAL, INCDZC2026-06-24
00840456209486JMUJMU DENTAL, INCDZC2026-06-24
00840456209493JMUJMU DENTAL, INCDZC2026-06-24
00840456209509JMUJMU DENTAL, INCDZC2026-06-24
00840456209516JMUJMU DENTAL, INCDZC2026-06-24
00840456209523JMUJMU DENTAL, INCDZC2026-06-24
00840456209530JMUJMU DENTAL, INCDZC2026-06-24
00840456209547JMUJMU DENTAL, INCDZC2026-06-24
00840456209554JMUJMU DENTAL, INCDZC2026-06-24
00840456209561JMUJMU DENTAL, INCDZC2026-06-24
00840456209578JMUJMU DENTAL, INCDZC2026-06-24
00840456209585JMUJMU DENTAL, INCDZC2026-06-24
00840456209592JMUJMU DENTAL, INCDZC2026-06-24