FDA.report

MEDENTiKA

Primary DI
EMKAPR14009
Brand
MEDENTiKA
Company
MEDENTiKA GmbH
Model
PR 1400
Catalog number
PR 1400
Device description
Scanbody
Published
2020-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04251574847683PrimaryGS10
EMKAPR14009SecondaryHIBCC0

GMDN Terms

TermDefinition
Dental implant suprastructure, temporary, preformed, reusableA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)448-8168Info.usa@straumann.com

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 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
08800055791203NB Master KitARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055791210NB Regular Kit ARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792774Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792804Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800076409996Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
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08800076423688URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423695URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423701URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
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