FDA.reportPublic FDA data

Ortho Pro

Primary DI
00810152826317
Brand
Ortho Pro
Company
Ortho Pro Dent LLC
Model
CSS-LR-M38
Device description
Bondable Lingual Retainers Maxillary 38 mm 10 pcs/pk
Published
2024-11-06
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
00810152826317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152826317008101528263178101528263170810152826317

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
941-402-6504edward@orthoprodent.com

Regulatory Flags#

DUNS number
085719913
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810152820902MAX-BONDOP96b-042024-11-04
00810152820919MAX-BONDOP96b-152024-11-04
00810152825556Orthodontic PlierOP-1002024-11-06
00810152825563Orthodontic PlierOP-1022024-11-06
00810152825570Orthodontic PlierOP-1032024-11-06
00810152825587Orthodontic PlierOP-1042024-11-06
00810152825594Orthodontic PlierOP-1052024-11-06
00810152825600Orthodontic PlierOP-1062024-11-06
00810152825617Orthodontic PlierOP-1072024-11-06
00810152825624Orthodontic PlierOP-1082024-11-06
00810152825631Orthodontic PlierOP-1092024-11-06
00810152825648Orthodontic PlierOP-1102024-11-06
00810152825655Orthodontic PlierOP-1112024-11-06
00810152825662Orthodontic PlierOP-1122024-11-06
00810152825679Orthodontic PlierOP-1132024-11-06
00810152825686Orthodontic PlierOP-1142024-11-06
00810152825693Orthodontic PlierOP-1152024-11-06
00810152825709Orthodontic PlierOP-1162024-11-06
00810152825716Orthodontic PlierOP-1172024-11-06
00810152825723Orthodontic PlierOP-1182024-11-06

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