FDA.reportPublic FDA data

MEDENTiKA

Primary DI
EMKABS80PSET9
Brand
MEDENTiKA
Company
MEDENTiKA GmbH
Model
BS 80-PS-ET
Catalog number
BS 80-PS-ET
Device description
Labimplant
Published
2019-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
EMKABS80PSET9PrimaryHIBCC0
04251574836939SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251574836939042515748369394251574836939

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-8168Info.usa@straumann.com

Regulatory Flags#

DUNS number
537555497
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251574835611MEDENTiKAL 60-ETL 60-ET2026-06-23
04251574835628MEDENTiKAN 62-ETN 62-ET2026-06-23
04251574853073MEDENTiKAMG 60-ETMG 60-ET2026-06-23
04251574862211MEDENTiKAL 68-ETL 68-ET2026-06-23
04251574862235MEDENTiKALX 60-ETLX 60-ET2026-06-23
04251574862983MEDENTiKAGM 61-ETGM 61-ET2026-06-23
04251574848505MEDENTiKAL 9000L 90002026-06-22
04251574848512MEDENTiKAL 9010L 90102026-06-22
04251574848543MEDENTiKAN 9010N 90102026-06-22
04251574848550MEDENTiKAN 9020N 90202026-06-22
04251574853165MEDENTiKAMG 9000MG 90002026-06-22
04251574855718MEDENTiKALX 9000LX 90002026-06-22
04251574856036MEDENTiKAL 9020L 90202026-06-22
04251574859174MEDENTiKALX 9010LX 90102026-06-22
04251574863072MEDENTiKAGM 9000GM 90002026-06-22
04251574845405MEDENTiKAOT 8503OT 85032026-05-13
04251574867803MEDENTiKA6-31-036-31-032026-05-13
04251574853134MEDENTiKAMG 80 TMG 80 T2026-04-21
04251574862228MEDENTiKAL 69-ETL 69-ET2026-02-20
04251574864901MEDENTiKAI 63-ETI 63-ET2026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNHA2026-07-13
07290114710411Healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712156Abutments-AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712613Titanium-basesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092184394PreatPreat CorporationNHA2025-07-24
D762MUA030500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA031000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA032000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA033000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA034000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345HCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345TBM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345VCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA035000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA040500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA041000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA042000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA043000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA044000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA045000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA050500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA051000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA052000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA053000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA054000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA055000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS0300010Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS1635230Implant-OneImplant Logistics, Inc.NHA2024-12-06