FDA.reportPublic FDA data

Preat Implant Prosthetics

Primary DI
00842092122396
Brand
Preat Implant Prosthetics
Company
Preat Corporation
Model
8001237
Catalog number
8001237
Device description
Straumann® TL-compatible RN Non-Engaging Verification Cylinder
Published
2022-11-22
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842092162590PackageGS110Not in Commercial Distribution
00842092122396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092162590008420921625908420921625900842092162590
00842092122396008420921223968420921223960842092122396

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

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
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
10841307135883Legacy™ DIRECTarch™ 3.0 MUA Replacement ScrewIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135890Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135906Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
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
10841307135968Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135975Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
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