FDA.reportPublic FDA data

Preat

Primary DI
00842092184493
Brand
Preat
Company
Preat Corporation
Model
710213
Catalog number
710213
Device description
PreatLoc™ Astra®-compatible Aqua Abutment 3mm
Published
2025-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
00842092184493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092184493008420921844938420921844930842092184493

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
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
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
00842092184516Preat7102217102212025-07-24
00842092184561Preat7107117107112025-07-24
00842092184578Preat7107127107122025-07-24
00842092184585Preat7107137107132025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968494068plant Implant System8dent Inc.NHA2026-10-20
088000968498338plant Implant System8dent Inc.NHA2026-10-20
088000968514618plant Implant System8dent Inc.NHA2026-10-20
088000968514788plant Implant System8dent Inc.NHA2026-10-20
088000968514858plant Implant System8dent Inc.NHA2026-10-20
088000968515778plant Implant System8dent Inc.NHA2026-10-20
088000968611568plant Implant System8dent Inc.NHA2026-10-20
088000968621608plant Implant System8dent Inc.NHA2026-10-20
088000968621778plant Implant System8dent Inc.NHA2026-10-20
088000968642878plant Implant System8dent Inc.NHA2026-10-20
088000968645778plant Implant System8dent Inc.NHA2026-10-20
088000968782398plant Implant System8dent Inc.NHA2026-10-20
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10841307135913Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 3.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135920Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 4.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135937Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 5.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135944Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135951Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
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10841307135982Legacy™ DIRECTarch™ 3.5 MUA Replacement ScrewIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135999Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136002Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136019Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 3.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136026Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 4.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136033Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 5.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136040Legacy™ DIRECTarch™ 3.5mmD Platform 17° MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136057Legacy™ DIRECTarch™ 3.5mmD Platform 17° MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20