FDA.reportPublic FDA data

Diastema

Primary DI
00190746074516
Brand
Diastema
Company
AMERICAN ORTHODONTICS CORPORATION
Model
855-252
Catalog number
855-252
Device description
DIASTEMA DB TUBE
Published
2019-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K893542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893542000DIASTEMA CLOSING KITAmerican Orthodontics1989-06-23EJF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190746074516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746074516001907460745161907460745160190746074516

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance system, adjustableAn assembly of devices such as metal bands, archwires, springs and/or power arms, designed to influence the shape and/or function of the stomatognathic system. Once applied to the teeth, it may be periodically adjusted to effect skeletal and/or dental changes by modifying and utilizing the neuromuscular forces of the stomatognathic system. It is typically used to correct malocclusions such as underbites, overbites, and cross bites, or crooked teeth and various other flaws of teeth and jaws, whether cosmetic or structural. Commonly known as a dental brace or orthodontic brace, it is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
044668515
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190746157073Luno001-033040001-0330402020-06-15
00190746150012Superelastic Titanium Memory857-54138TQSPW857-54138TQSPW2019-08-12
00190746150029Superelastic Titanium Memory857-54234TQSPW857-54234TQSPW2019-08-12
00190746150036Superelastic Titanium Memory857-54238TQSPW857-54238TQSPW2019-08-12
00190746150098Superelastic Titanium Memory857-551TQSPW857-551TQSPW2019-08-12
00190746150104Superelastic Titanium Memory857-552TQSPW857-552TQSPW2019-08-12
00190746150128Superelastic Titanium Memory857-554TQSPW857-554TQSPW2019-08-12
00190746148354Superelastic Titanium Memory857-731W857-731W2019-08-09
00190746007835Procelain Conditioner001-966001-9662016-11-09
00190746133282Rapid Molar Intruder852-202852-2022018-07-05
00190746133299Rapid Molar Intruder852-203852-2032018-07-05
00190746096112MasterSeries390-8712B390-8712B2018-08-03
00190746096334MasterSeries390-8713B390-8713B2018-08-03
00190746097904MasterSeries390-8716B390-8716B2018-08-03
00190746098093MasterSeries390-8717B390-8717B2018-08-03
00190746203770Weldable Cleat852-166852-1662026-04-21
00190746203787Weldable Cleat852-166PK852-166PK2026-04-21
00190746203794Weldable Cleat852-168PK852-168PK2026-04-21
00190746203800Weldable Cleat852-168852-1682026-04-21
00190746203817Weldable Cleat852-167PK852-167PK2026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456205389JMUJMU DENTAL, INCEJF2026-06-25
00840456205396JMUJMU DENTAL, INCEJF2026-06-25
00840456205402JMUJMU DENTAL, INCEJF2026-06-25
00840456205419JMUJMU DENTAL, INCEJF2026-06-25
00840456205914JMUJMU DENTAL, INCEJF2026-06-25
00840456205921JMUJMU DENTAL, INCEJF2026-06-25
00840456205938JMUJMU DENTAL, INCEJF2026-06-25
00840456205945JMUJMU DENTAL, INCEJF2026-06-25
00840456205952JMUJMU DENTAL, INCEJF2026-06-25
00840456205969JMUJMU DENTAL, INCEJF2026-06-25
00840456205976JMUJMU DENTAL, INCEJF2026-06-25
00840456205983JMUJMU DENTAL, INCEJF2026-06-25
00840456205990JMUJMU DENTAL, INCEJF2026-06-25
00840456206003JMUJMU DENTAL, INCEJF2026-06-25
00840456206010JMUJMU DENTAL, INCEJF2026-06-25
00840456206027JMUJMU DENTAL, INCEJF2026-06-25
00860013236601VECS Palate ExpanderAZURE MICRODYNAMICS, INC.EJF2026-06-05
00860013236618VECS Palate ExpanderAZURE MICRODYNAMICS, INC.EJF2026-06-05
00860013236625VECS Lab KitAZURE MICRODYNAMICS, INC.EJF2026-06-05
00860013236632VECS Activation KeyAZURE MICRODYNAMICS, INC.EJF2026-06-05
07908611216748METAL BRACKET U-CLIP PASSIVE ROTH 0,022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216755METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U1R (11) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216762METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U2R (12) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216779METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U3R (13) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216786METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U45R (14/15) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216793METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U1L (21) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216809METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U2L (22) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216816METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U3L (23) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216823METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U45L (24/25) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216830METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L12RL (31/32/41/42) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12