FDA.reportPublic FDA data

Legacy-compatible

Primary DI
00842092182147
Brand
Legacy-compatible
Company
Preat Corporation
Model
9008503
Catalog number
9008503
Device description
Legacy-compatible 5.7mm Digital Analog Kit Contains: 1 Legacy-compatible 5.7mm Digital Analog 1 Digital Analog Base Screw
Published
2024-02-07
Public version status
New
Distribution status
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842092182147PackageGS110In Commercial Distribution
00842092182130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092182147008420921821478420921821470842092182147
00842092182130008420921821308420921821300842092182130

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, scanningA non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117776048
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

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
00844868052463T3® ProZimVie US Corp LLCNDP2026-05-28
00844868052470T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052487T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052494T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052500T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052517T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052524T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052531T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052548T3® ShortZimVie US Corp LLCNDP2026-05-28
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
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