FDA.reportPublic FDA data

MEDENTiKA

Primary DI
EMKAI4110
Brand
MEDENTiKA
Company
MEDENTiKA GmbH
Model
I 4110
Device description
MedentiBASE abutment
Published
2015-10-30
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
K142167000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142167000MEDENTIKA ABUTMENT SYSTEMMedentika GmbH2015-02-20NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMKAI4110PrimaryHIBCC0

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.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)412-8883Info.us@instradent.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04251574866806MEDENTiKAK 65K 652026-02-20
04251574867780MEDENTiKAK 65-ETK 65-ET2026-02-20
04251574867216MEDENTiKAE 9000-ASE 9000-AS2026-02-12
04251574867223MEDENTiKAE 9010-ASE 9010-AS2026-02-12
04251574867230MEDENTiKAE 9020-ASE 9020-AS2026-02-12
04251574867247MEDENTiKAE 9030-ASE 9030-AS2026-02-12
04251574867254MEDENTiKAEV 9000-ASEV 9000-AS2026-02-12
04251574867261MEDENTiKAEV 9010-ASEV 9010-AS2026-02-12
04251574867278MEDENTiKAEV 9020-ASEV 9020-AS2026-02-12
04251574867285MEDENTiKAEV 9030-ASEV 9030-AS2026-02-12
04251574867292MEDENTiKAEV 9040-ASEV 9040-AS2026-02-12
04251574867308MEDENTiKAF 9000-ASF 9000-AS2026-02-12
04251574867315MEDENTiKAF 9010-ASF 9010-AS2026-02-12
04251574867322MEDENTiKAF 9020-ASF 9020-AS2026-02-12
04251574867339MEDENTiKAF 9030-ASF 9030-AS2026-02-12

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