FDA.reportPublic FDA data

Sphero Attachments

Primary DI
00842092108512
Brand
Sphero Attachments
Company
Preat Corporation
Model
0800512
Catalog number
0800512
Device description
Sphero Flex Post Medium 7.50mm
Published
2016-09-16
Public version status
Update
Distribution status
Not 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
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842092108512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092108512008420921085128420921085120842092108512

GMDN Terms#

Term, Definition table
TermDefinition
Partial dentureA custom-made, removeable, artificial replacement for one or more, but not all, teeth in the lower or upper jaw (mandible or maxilla) in a partially edentulous patient. It typically includes clasps of metal or plastic that clip onto remaining teeth for retention and stabilization. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)]. Also known as a removable partial denture (RPD).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 232-7732info@preat.com

Regulatory Flags#

DUNS number
117776048
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842092170199Preat9001230-109001230-102026-06-09
00842092174999Preat9003731-1009003731-1002026-06-09
00842092187722Preat7100033-27100033-22026-06-08
00842092116906Implant Prosthetics800125080012502016-09-16
00842092117217Implant Prosthetics800165080016502016-09-16
00842092117491Implant Prosthetics800055080005502016-09-16
00842092110669FR Attachments070204007020402023-07-05
00842092112076Preat06000F906000F92022-10-25
00842092112113Preat Implant Prosthetics0600F130600F132023-07-03
00842092122396Preat Implant Prosthetics800123780012372022-11-22
00842092155844Implantlink090751009075102022-10-25
00842092167601Preat0600F160600F162022-10-25
00842092167618Preat060406606040662022-10-25
00842092172544Preat010900301090032022-10-24
00842092172551Preat010900501090052022-10-24
00842092175590Preat010200701020072022-10-25
00842092175606Preat010200801020082022-10-25
00842092176696Preci-Clix01004TI01004TI2022-10-27
00842092110577Mays020006002000602023-10-17
00842092110737Splintastik020000102000012023-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08809822767892AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767908AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767922AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767946AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767953AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12