FDA.reportPublic FDA data

Debond Wafers

Primary DI
00190746034923
Brand
Debond Wafers
Company
AMERICAN ORTHODONTICS CORPORATION
Model
861-015
Catalog number
861-015
Device description
SUPPLIES - DEBOND WAFER 52/PKG
Published
2022-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGDWAX, DENTAL, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190746034923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746034923001907460349231907460349230190746034923

GMDN Terms#

Term, Definition table
TermDefinition
Bite registration rim wax, plateA dental material (modelling wax) delivered as prefabricated plates of wax with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Light
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags#

DUNS number
044668515
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
true
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190746067549PowerScope852-016539852-0165392026-03-24
00190746067563PowerScope852-016540852-0165402026-03-24
00190746067587PowerScope852-030576852-0305762026-03-24
00190746153273PowerScope852-016541852-0165412026-03-24
00190746202742PowerScope852-016538852-0165382026-03-24
00190746202759PowerScope852-016537852-0165372026-03-24
00190746191602Empower Bracket475-1112VSCC475-1112VSCC2026-03-23
00190746191619Empower Bracket475-128VSCC475-128VSCC2026-03-23
00190746191626Empower Bracket475-2112VSCC475-2112VSCC2026-03-23
00190746191633Empower Bracket475-228VSCC475-228VSCC2026-03-23
00190746191640Empower Bracket475-310VSCC475-310VSCC2026-03-23
00190746191657Empower Bracket475-410VSCC475-410VSCC2026-03-23
00190746191664Empower Bracket585-130BVSCC585-130BVSCC2026-03-23
00190746191671Empower Bracket585-140BVSCC585-140BVSCC2026-03-23
00190746191688Empower Bracket585-140VSCC585-140VSCC2026-03-23
00190746191695Empower Bracket585-230BVSCC585-230BVSCC2026-03-23
00190746191701Empower Bracket585-240BVSCC585-240BVSCC2026-03-23
00190746191718Empower Bracket585-240VSCC585-240VSCC2026-03-23
00190746191725Empower Bracket585-330BVSCC585-330BVSCC2026-03-23
00190746191732Empower Bracket585-340BVSCC585-340BVSCC2026-03-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840479203331RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-03-12
00840479200552RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-02-23
00840479200569RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-02-23
06978785665070InhwRiorShenzhen Yuechuan trade Co., Ltd.EGD2025-12-08
10190707193215Orthosil™Ortho Organizers, Inc.EGD2025-10-23
10190707149045Comfort Cover™Ortho Organizers, Inc.EGD2025-10-01
10190707143005Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143012Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143029Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143036Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143043Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143050Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143067Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143074Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143081Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143098Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
E235S3DCR0DentaprintSHOFU DENTAL CORPORATIONEGD2025-08-26
07701126901150Portux 3D Printing Resin CastPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEGD2025-08-11
07701126901228Portux 3D Printing Resin CastPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEGD2025-08-11
00840456207604JMUJMU DENTAL, INCEGD2025-07-15
00840456207611JMUJMU DENTAL, INCEGD2025-07-15
00840456207628JMUJMU DENTAL, INCEGD2025-07-15
00840456207635JMUJMU DENTAL, INCEGD2025-07-15
00840456207642JMUJMU DENTAL, INCEGD2025-07-15
16978785665046InhwRiorShenzhen Yuechuan trade Co., Ltd.EGD2025-07-09
06978785665049InhwRiorShenzhen Yuechuan trade Co., Ltd.EGD2025-07-09
07506338322454ROGSON WAX, MDC Dental MDC DENTALEGD2025-05-16
00190886135498NAG & H Wire Company, Inc.EGD2025-03-31
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