FDA.reportPublic FDA data

MEDENTiKA

Primary DI
EMKAM689
Brand
MEDENTiKA
Company
MEDENTiKA GmbH
Model
M 68
Catalog number
M 68
Device description
Abutment remover
Published
2022-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251574822925PrimaryGS10
EMKAM689PrimaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251574822925042515748229254251574822925

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis removerA non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or implant abutment; it is not a thermal detacher. It consists of a metallic instrument with a handle and a pointed, angled distal end used to secure the instrument at the margin of the prosthesis to be removed; it may be designed as a manual, pneumatic or spring-loaded instrument whereby light force is applied to detach the restoration. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
537555497
Device count
1
DM exempt
false
Premarket exempt
true
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
04251574872852MEDENTiKAE 9000-GHE 9000-GH2026-09-22
04251574872869MEDENTiKAE 9010-GHE 9010-GH2026-09-22
04251574872876MEDENTiKAE 9020-GHE 9020-GH2026-09-22
04251574872883MEDENTiKAE 9030-GHE 9030-GH2026-09-22
04251574872890MEDENTiKAEV 9000-GHEV 9000-GH2026-09-22
04251574872906MEDENTiKAEV 9010-GHEV 9010-GH2026-09-22
04251574872913MEDENTiKAEV 9020-GHEV 9020-GH2026-09-22
04251574872920MEDENTiKAEV 9030-GHEV 9030-GH2026-09-22
04251574872937MEDENTiKAEV 9040-GHEV 9040-GH2026-09-22
04251574872944MEDENTiKAF 9000-GHF 9000-GH2026-09-22
04251574872951MEDENTiKAF 9010-GHF 9010-GH2026-09-22
04251574872968MEDENTiKAF 9020-GHF 9020-GH2026-09-22
04251574872975MEDENTiKAF 9030-GHF 9030-GH2026-09-22
04251574872982MEDENTiKAH 9000-GHH 9000-GH2026-09-22
04251574872999MEDENTiKAH 9010-GHH 9010-GH2026-09-22
04251574873002MEDENTiKAH 9020-GHH 9020-GH2026-09-22
04251574873019MEDENTiKAI 9000-GHI 9000-GH2026-09-22
04251574873026MEDENTiKAI 9010-GHI 9010-GH2026-09-22
04251574873033MEDENTiKAI 9020-GHI 9020-GH2026-09-22
04251574873040MEDENTiKAK 9000-GHK 9000-GH2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E0HM36KHKS1Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungNDP2026-10-23
07392532032349Bone TrapDentsply Implants Manufacturing GmbHNDP2026-10-16
06009544052913N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-14
08809918259713LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
08809918259720LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
03700977513110SlimEUROTEKNIKANDP2026-10-12
03700977513363iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513370iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513387iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513394iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513400iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513417iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513424iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513431iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513448iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513455iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513462iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513639iFlag ReversoEUROTEKNIKANDP2026-10-12
07290116661322Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-10-11
00810157315762MUA PEEK Comfort CapParagon Implant Mfg., LLCNDP2026-10-09
06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
07899878068143NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068150NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068167NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068174NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07