FDA.report

MEDENTiKA

Primary DI
EMKAM069
Brand
MEDENTiKA
Company
MEDENTiKA GmbH
Model
M 06
Catalog number
M 06
Device description
Screw 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

Related Records

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04251574822598PrimaryGS10
EMKAM069PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant extractorA manually-operated, one-piece dental device intended to be used to retrieve an in situ dental implant [i.e., anchorage and/or retention (abutment) component], typically because of damage (e.g., a broken collar) or malfunction, from the oral cavity. It typically has a cylindrical design and a cavity or threaded shaft at the working distal end intended to grip or be inserted into the implant. It may have a handle at the proximal end or be used in conjunction with a drill and/or a separate handle or wrench (not included); it is not a collection of devices (i.e., not a kit). This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

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

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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

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