FDA.reportPublic FDA data

Universal IC Attachment

Primary DI
00816577023683
Brand
Universal IC Attachment
Company
Preat Corporation
Model
1200112
Catalog number
1200112
Device description
Universal IC Attachment
Published
2022-06-28
Public version status
Update
Distribution status
Not 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
EHOBAR, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHOBar, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816577023683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816577023683008165770236838165770236830816577023683

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) 232-7732lauren@preat.com
+1(800) 232-7732info@preat.com

Regulatory Flags#

DUNS number
117776048
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842092186671Preat710101-18710101-182026-05-07
00842092186688Preat710103-18710103-182026-05-07
00842092186695Preat710105-18710105-182026-05-07
00842092186701Preat710041-18710041-182026-05-07
00842092186718Preat710043-18710043-182026-05-07
00842092186725Preat710045-18710045-182026-05-07
00842092186732Preat710051-18710051-182026-05-07
00842092186749Preat710053-18710053-182026-05-07
00842092186756Preat710055-18710055-182026-05-07
00842092186763Preat710121-18710121-182026-05-07
00842092186770Preat710122-18710122-182026-05-07
00842092186787Preat710123-18710123-182026-05-07
00842092186794Preat710161-18710161-182026-05-07
00842092186800Preat710162-18710162-182026-05-07
00842092186817Preat710163-18710163-182026-05-07
00842092186824Preat710164-18710164-182026-05-07
00842092186831Preat710165-18710165-182026-05-07
00842092186848Preat710171-18710171-182026-05-07
00842092186855Preat710172-18710172-182026-05-07
00842092186862Preat710173-18710173-182026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776352066MillenniumAvalign Technologies, Inc.EHO2023-06-23
EZPF41905000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEHO2022-12-07
EZPF41905010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEHO2022-12-07
EZPF4190702S0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEHO2022-12-07
07630031724502NAInstitut Straumann AGEHO2022-11-10
07630031724519NAInstitut Straumann AGEHO2022-11-10
00842092112847HaderPreat CorporationEHO2022-10-24
00842092113103PreatPreat CorporationEHO2022-10-24
00842092129784PreatPreat CorporationEHO2022-10-24
00842092130834PreatPreat CorporationEHO2022-10-24
00842092131923PreatPreat CorporationEHO2022-10-24
00842092133224PreatPreat CorporationEHO2022-10-24
00842092133231PreatPreat CorporationEHO2022-10-24
00842092133330PreatPreat CorporationEHO2022-10-24
00842092133408PreatPreat CorporationEHO2022-10-24
00842092133576PreatPreat CorporationEHO2022-10-24
00842092134450PreatPreat CorporationEHO2022-10-24
00842092134467PreatPreat CorporationEHO2022-10-24
00842092134610PreatPreat CorporationEHO2022-10-24
00842092136522PreatPreat CorporationEHO2022-10-24
00842092139745PreatPreat CorporationEHO2022-10-24
00842092139769PreatPreat CorporationEHO2022-10-24
00842092139783PreatPreat CorporationEHO2022-10-24
00842092139806PreatPreat CorporationEHO2022-10-24
00842092139837PreatPreat CorporationEHO2022-10-24
00842092139851PreatPreat CorporationEHO2022-10-24
00842092139875PreatPreat CorporationEHO2022-10-24
00842092139882PreatPreat CorporationEHO2022-10-24
00842092139905PreatPreat CorporationEHO2022-10-24
00842092139929PreatPreat CorporationEHO2022-10-24