Elos Accurate Hybrid Base

Abutment, Implant, Dental, Endosseous

Elos Medtech Pinol A/S

The following data is part of a premarket notification filed by Elos Medtech Pinol A/s with the FDA for Elos Accurate Hybrid Base.

Pre-market Notification Details

• Device ID: K201860
• 510k Number: K201860
• Device Name: Elos Accurate Hybrid Base
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: Elos Medtech Pinol A/S Engvej 33 Goerloese, DK Dk-3330
• Contact: Tina Friis Poulsen
• Correspondent: Tina Friis Poulsen; Elos Medtech Pinol A/S Engvej 33 Goerloese, DK Dk-3330
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-07-06
• Decision Date: 2021-02-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05712821000576	K201860	000
05712821006912	K201860	000
05712821006936	K201860	000
05712821006943	K201860	000
05712821006950	K201860	000
05712821006967	K201860	000
05712821006974	K201860	000
05712821006981	K201860	000
05712821006998	K201860	000
05712821007001	K201860	000
05712821007018	K201860	000
05712821007100	K201860	000
05712821007117	K201860	000
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05712821007179	K201860	000
05712821007186	K201860	000
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05712821006899	K201860	000
05712821006844	K201860	000
05712821000583	K201860	000
05712821000590	K201860	000
05712821001115	K201860	000
05712821001849	K201860	000
05712821002082	K201860	000
05712821002235	K201860	000
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05712821002259	K201860	000
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05712821006790	K201860	000
05712821006806	K201860	000
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05712821006820	K201860	000
05712821006837	K201860	000
05712821007193	K201860	000
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05712821003454	K201860	000
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05712821003607	K201860	000
05712821003614	K201860	000
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05712821003638	K201860	000
05712821003645	K201860	000
05712821008343	K201860	000
05712821008350	K201860	000
05712821008367	K201860	000
05712821008299	K201860	000
05712821008305	K201860	000
05712821008312	K201860	000
05712821008329	K201860	000
05712821008336	K201860	000
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05712821007476	K201860	000
05712821007483	K201860	000
05712821006929	K201860	000