Atlas FDA

PRESIDENT The Original

FDA 510(k) clearance K220097 · decided 2022-01-13

Clearance details

K-number
K220097
Device name
PRESIDENT The Original
Applicant
Coltène/Whaledent AG
Decision
Substantially Equivalent
Date received
2022-01-12
Decision date
2022-01-13
Days to decision
1 days
Clearance type
Traditional
Product code
ELW
Device class
2
Regulation number
872.3660
Medical specialty
Dental
Advisory committee
Dental
Location
Altstätten, CH
Third-party review
Yes
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Dia-X Sil Bite (K254112)DiaDent Group International2026-03-19
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JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST (K250969)Dent4you AG2025-06-27
Elastic Impression Material (K241924)Beijing Okvd Biological Technology , Ltd.2024-12-27
Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (K242360)Dent4you AG2024-11-15
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu (K233954)B&E Korea Co., Ltd.2024-02-13
DentMix VPS Impression Material (K223892)Innovative Product Brands, Inc.2023-04-27
No Stress Impress (K213175)No Stress Impress, LLC2023-01-19
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty (K214086)Genoss Co., Ltd.2022-12-15
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) (K222741)Hdi, Inc.2022-11-07
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) (K213244)Prevest Denpro Limited2022-09-09
Dental Impression Material (K221668)Chemoment Materials Co.,Ltd2022-08-08

Recalls involving this device

No recalls on record reference this clearance.