FDA.reportPublic FDA data

1mm Round Spacer, Pk/10

Primary DI
00889989087703
Brand
1mm Round Spacer, Pk/10
Company
ALLESEE AOA-PRO
Model
MATER07
Device description
1mm Round Spacer, Pk/10
Published
2023-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889989087703PrimaryGS10
10889989087700Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989087703008899890877038899890877030889989087703
1088998908770010889989087700

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic clasp, metal, custom-madeA dental device made of cast metal material intended to retain and stabilize a removable orthodontic appliance to stationary teeth. It is manufactured to meet the specifications of an individual patient. 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
+12628861050more.information@aoalab.com

Regulatory Flags#

DUNS number
158312728
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
00889989087864AOB Splint3000-01282023-04-05
00889989087871Bruxism Splint3000-01272023-04-05
00889989087888Damon Retention Splint3000-01262023-04-05
00889989087895Bite Orthotic Appliance3000-01252023-04-05
00889989087901Intrusion Splint3000-01242023-04-05
00889989087918Mora-Gelb Splint3000-01222023-04-05
00889989087925Flat Plane Splint3000-01212023-04-05
00889989088021Flexiclear3000-00612023-04-05
00889989074468Repositioning Splint3000-01232023-03-13
00889989088571Prezurv Plus3000-01382024-05-03
00889989081817Memotain3000-01352023-07-24
00889989087642Archwire Extender Accessory, Size .022, Cast Body, Pk of 101604-33222023-04-05
00889989087673Herbst Pistons, Pk/2MATER012023-04-05
00889989087680Herbst Sleeves, setMATER022023-04-05
008899890876975.5mm Hex Screw, Pk/10MATER05A2023-04-05
008899890877102mm Round Spacer, Pk/10MATER082023-04-05
008899890877273mm Round Spacer, Pk/10MATER092023-04-05
008899890877344mm Round Spacer, Pk/10MATER102023-04-05
00889989087741AppleCore Screw, Pk/10MATER1002023-04-05
00889989087758MiniScope Mechanism 18mm, setMATER1012023-04-05

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