Atlas FDA

Preat Abutments

FDA 510(k) clearance K220823 · decided 2022-10-26

Clearance details

K-number
K220823
Device name
Preat Abutments
Applicant
Preat Corporation
Decision
Substantially Equivalent
Date received
2022-03-21
Decision date
2022-10-26
Days to decision
219 days
Clearance type
Traditional
Product code
NHA
Device class
2
Regulation number
872.3630
Medical specialty
Dental
Advisory committee
Dental
Location
Santa Maria, CA, US
Third-party review
No
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
Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw (K253999)Nobel Biocare AB2026-08-06
Neodent Implant System - NeoConvert Fit (K261147)JJGC Indústria e Comércio de Materiais Dentários S.A.2026-07-01
MIST IC (K261122)Imagine Milling Technologies, LLC2026-06-27
BioHorizons CEREC Compatible Ti-Bases (K260061)BioHorizons Implant Systems, Inc.2026-06-26
Neodent Scannable Healing Abutment (K253922)JJGC Indústria e Comércio de Materiais Dentários S.A.2026-06-15
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (K254145)Smart Denture Conversions, LLC2026-06-11
DESS Dental Smart Solutions (K260564)Terrats Medical SL2026-06-09
SIC Abutments including CAD/CAM Solutions (K252904)Sic Invent AG2026-06-03
Elos Accurate® Denture Fixation System (K253774)Elos Medtech Pinol A/S2026-05-20
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments (K253372)Hiossen, Inc.2026-05-14
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue (K260460)Institut Straumann AG2026-05-07
DESS Dental Smart Solutions (K253804)Terrats Medical SL2026-04-16

Recalls involving this device

RecordFirmDate
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pa recall (Z-2107-2025)Preat Corp2025-07-10
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjun recall (Z-2318-2024)Preat Corp2024-07-08
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Onl recall (Z-0152-2024)Preat Corp2023-10-24
Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Onl recall (Z-0153-2024)Preat Corp2023-10-24
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single recall (Z-0154-2024)Preat Corp2023-10-24
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 recall (Z-1285-2023)Preat Corp2023-03-24