# Elos Medtech Pinol A/S

- Location (FDA's records): Goerloese, DK
- FDA decisions: 14 (2018–2026): 14 510(k) clearances
- Product codes: NHA (14)
- 510(k) review time since 2016: median 168 days, against 156 for FDA's reviews in the same codes and years (5 of 14 faster)
- Predicates its devices cite: 17 (14 its own); citations of its devices by later devices: 20 (14 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medentika GmbH: 1 (https://510kreport.com/company/medentika)
- Terrats Medical SL: 1 (https://510kreport.com/company/terrats-medical)
- Ivory Super Holdco, Incp.: 1 (https://510kreport.com/company/ivory-super-holdco-incp)

## Firms that cite its devices most
- Implant Protesis Dental 2004, S.L.: 1 (https://510kreport.com/company/implant-protesis-dental-2004)
- Warantec Co., Ltd.: 1 (https://510kreport.com/company/warantec)
- BioHorizons Implant Systems, Inc.: 1 (https://510kreport.com/company/biohorizons-implant-systems)
- Arum Dentistry Co., Ltd.: 1 (https://510kreport.com/company/arum-dentistry)
- Elegant Dental Corp.: 1 (https://510kreport.com/company/elegant-dental)
- Nobel Biocare AB: 1 (https://510kreport.com/company/nobel-biocare)

## Its most-cited devices
- K190299: Elos Accurate® Customized Abutment (2019), cited by 4
- K171799: Elos Accurate Customized Abutment, Elos Prosthetic Screw (2018), cited by 3
- K192457: Elos Accurate Customized Abutment (2020), cited by 2
- K242025: Elos Accurate® Hybrid Base™ (2024), cited by 2
- K230317: Elos Accurate Hybrid Base (2023), cited by 2
- K222044: Elos Accurate Customized Abutment (2022), cited by 2

## Recent decisions
- K261327: Elos Accurate Hybrid Base (Sep 30, 2026)
- K253774: Elos Accurate® Denture Fixation System (May 20, 2026)
- K251497: Elos Accurate Hybrid Base (Oct 16, 2025)
- K242025: Elos Accurate® Hybrid Base™ (Dec 10, 2024)
- K241722: Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment (Sep 13, 2024)
- K231307: Elos Accurate Customized Abutment (Dec 21, 2023)
- K230317: Elos Accurate Hybrid Base (Sep 1, 2023)
- K222044: Elos Accurate Customized Abutment (Nov 30, 2022)

Source page: https://510kreport.com/company/elos-medtech-pinol-a-s