FDA.reportPublic FDA data

Hayrake-Palatal with Spurs

Primary DI
00889989083545
Brand
Hayrake-Palatal with Spurs
Company
ALLESEE AOA-PRO
Model
3000-0073
Device description
Hayrake-Palatal with Spurs
Published
2023-03-13
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
KMYPOSITIONER, TOOTH, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889989083545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989083545008899890835458899890835450889989083545

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic habit prevention/breaking appliance, bondedAn orthodontic device intended to be bonded (fixed) to the teeth of a child to prevent or help break habits (typically finger sucking or tongue thrusting) that adversely affect the position of developing dentition. It is typically in the form of pins, a small sphere, or a circular/discoid structure held in the palate with wires and metal bands. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+12628861050more.information@aoalab.com

Regulatory Flags#

DUNS number
158312728
Device count
1
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
008899890877031mm Round Spacer, Pk/10MATER072023-04-05
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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H66841101411KeyPrintKeystone IndustriesKMY2023-09-25
H66842201511KeyPrintKeystone IndustriesKMY2023-09-25
08719425509549Vertex-Dental BVVertex-Dental B.V.KMY2023-06-20
08719425509556NextDentVertex-Dental B.V.KMY2023-06-15
H66842000111KeyPrintKeystone IndustriesKMY2023-02-20
H66842001611KeyPrintKeystone IndustriesKMY2023-02-20
H66842200111KeyPrintKeystone IndustriesKMY2023-02-20
H66842201141HeyGearsKeystone IndustriesKMY2023-02-20
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EPRCD1001611PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
H668210241American DentalKeystone IndustriesKMY2022-11-30
H668210251American DentalKeystone IndustriesKMY2022-11-30
H668210261American DentalKeystone IndustriesKMY2022-11-30
H668210271American DentalKeystone IndustriesKMY2022-11-30
H668210341American DentalKeystone IndustriesKMY2022-11-30
EPRCD1001703PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRCD1001704PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
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EPRCD1000800PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
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EPRCD1001492PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001493PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001701PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
EPRCD1001702PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
ERKO5142052ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
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