FDA.reportPublic FDA data

Straumann

Primary DI
00842092129456
Brand
Straumann
Company
Preat Corporation
Model
8001423
Catalog number
8001423
Device description
Straumann® BL RC-compatible Healing Abutment - 6.0 x 5.0mm
Published
2022-10-24
Public version status
Update
Distribution status
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
NHAAbutment, implant, dental, endosseous

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142118000INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAEPrismatik Dentalcraft, Inc.2014-11-25NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842092129456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092129456008420921294568420921294560842092129456

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) 232-7732lauren@preat.com
+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
00842092185391Preat7105407105402025-12-22
00842092185414Preat7105427105422025-12-22
00842092185421Preat7105437105432025-12-22
00842092185438Preat7105447105442025-12-22
00842092185445Preat7105457105452025-12-22
00842092185452Preat7105507105502025-12-22
00842092184257Preat7101717101712025-07-24
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
00842092184592Preat7107147107142025-07-24
00842092184608Preat7107157107152025-07-24
00842092184615Preat7107167107162025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260516877992SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
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04260516878029SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878036SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878043SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878050SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878067SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878074SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878081SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878098SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878104SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878111SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878128SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878135SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878142SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878159SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878166SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878173SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878180SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
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04099797001136CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001143CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001150CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001167CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001174CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001181CONELOG® Healing capALTATEC GmbHNHA2026-08-17