FDA.reportPublic FDA data

Preat

Primary DI
00842092184516
Brand
Preat
Company
Preat Corporation
Model
710221
Catalog number
710221
Device description
PreatLoc® Astra®-compatible Lilac Abutment 0.5mm
Published
2025-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222288000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222288000DESS Dental Smart SolutionsTerrats Medical SL2022-10-27NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842092184516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092184516008420921845168420921845160842092184516

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

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
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842092184301Preat7100107100102025-12-22
00842092184370Preat7100207100202025-12-22
00842092185391Preat7105407105402025-12-22
00842092185414Preat7105427105422025-12-22
00842092185421Preat7105437105432025-12-22
00842092185438Preat7105447105442025-12-22
00842092185445Preat7105457105452025-12-22
00842092185452Preat7105507105502025-12-22
00842092184257Preat7101717101712025-07-24
00842092184394Preat7100227100222025-07-24
00842092184400Preat7100237100232025-07-24
00842092184417Preat7100247100242025-07-24
00842092184424Preat7100257100252025-07-24
00842092184448Preat7100327100322025-07-24
00842092184455Preat7100337100332025-07-24
00842092184462Preat7100347100342025-07-24
00842092184561Preat7107117107112025-07-24
00842092184578Preat7107127107122025-07-24
00842092184585Preat7107137107132025-07-24
00842092184592Preat7107147107142025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112922530(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922547(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922554(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922561(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922578(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922585(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922592(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922608(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922615(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922622(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922639(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922646(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922653(INOSS System) Abutment ScrewInosys, Inc.NHA2026-08-27
08059224217932OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217949OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217956OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217963OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217970OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217987OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217994OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218021OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218045OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218052OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218069OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218076OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218083OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218090OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218106OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218113OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218120OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27