Atlas FDA

Adin Short Implants

FDA 510(k) clearance K212775 · decided 2022-07-08

Clearance details

K-number
K212775
Device name
Adin Short Implants
Applicant
Adin Dental Implants Systems , Ltd.
Decision
Substantially Equivalent
Date received
2021-09-01
Decision date
2022-07-08
Days to decision
310 days
Clearance type
Traditional
Product code
DZE
Device class
2
Regulation number
872.3640
Medical specialty
Dental
Advisory committee
Dental
Location
Afula, IL
Third-party review
No
Expedited review
No

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

RecordFirmDate
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ZENEX Implant System_Short (R-System) (K253334)Izenimplant Co., Ltd.2026-03-16
Straumann® BLC Implants - Indication Widening (K252168)Institut Straumann AG2026-03-10
Dentis SQ-SL AXEL Fixture (K253493)Dentis Co., Ltd.2026-03-04
Nobel Biocare S Series Implants (K252197)Nobel Biocare AB2026-02-18
BIORES Dental Implant System (K252286)Chengdu Besmile Medical Technology Co., Ltd.2026-02-02
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Recalls involving this device

No recalls on record reference this clearance.