FDA.report

MEDENTiKA

Primary DI
EMKAR820
Brand
MEDENTiKA
Company
MEDENTiKA GmbH
Model
R 820
Device description
Titanium Base
Published
2016-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EMKAR820PrimaryHIBCC0

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(855)412-8883Info.us@instradent.com

Regulatory Flags

DUNS number
537555497
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
04251574865755MedentikaE 1400-SBE 1400-SB2025-09-19
04251574865762MedentikaE 1410-SBE 1410-SB2025-09-19
04251574865779MedentikaE 1420-SBE 1420-SB2025-09-19
04251574865786MedentikaE 1430-SBE 1430-SB2025-09-19
04251574865823MedentikaEV 1400-SBEV 1400-SB2025-09-19
04251574865830MedentikaEV 1410-SBEV 1410-SB2025-09-19
04251574865847MedentikaEV 1420-SBEV 1420-SB2025-09-19
04251574865854MedentikaEV 1430-SBEV 1430-SB2025-09-19
04251574865861MedentikaEV 1440-SBEV 1440-SB2025-09-19
04251574865892MedentikaF 1400-SBF 1400-SB2025-09-19
04251574865908MedentikaF 1410-SBF 1410-SB2025-09-19
04251574865915MedentikaF 1420-SBF 1420-SB2025-09-19
04251574865960MedentikaH 1400-SBH 1400-SB2025-09-19
04251574865977MedentikaH 1410-SBH 1410-SB2025-09-19
04251574866011MedentikaI 1400-SBI 1400-SB2025-09-19
04251574866028MedentikaI 1410-SBI 1410-SB2025-09-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07290120481039IH Straight Shoulder Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120481237IH Straight Shoulder Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120481435IH Straight Shoulder Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482470IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482524IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482579IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482623IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482678IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486621NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486676NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486720NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486775NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486829NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486874RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486928RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486973RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487024RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487079RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487383NP Straight Anatomic Abutment 3.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487437RP Straight Anatomic Abutment 5.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487482RP Straight Anatomic Abutment 5.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487529IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487536NP Straight Anatomic Abutment 3.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487628IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487727IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487826IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120488328IH Straight Anatomic Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120488427IH Straight Anatomic Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120488526IH Straight Anatomic Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120488625IH Straight Anatomic Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24