510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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TruAbutment Inc.

Irvine, CA, US

TRUABUTMENT INC. appears in FDA device records in Irvine, CA. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
17
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 17 510(k) clearances for TruAbutment Inc. between 2016 and 2025. The busiest year on record is 2021, with 4. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for TruAbutment Inc., by decision year
YearClearances
20161
20171
20183
20203
20214
20221
20232
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243255URIS Long Implant & AbutmentsDZESubstantially Equivalent
K241485TruAbutment DS; TruBaseNHASubstantially Equivalent
K230438URIS Smart Path Implant System & ProstheticDZESubstantially Equivalent
K231874AOT & T-L AbutmentNHASubstantially Equivalent
K213961TruAbutment DS, TruBaseNHASubstantially Equivalent
K203649TruAbutment DS, TruBaseNHASubstantially Equivalent
K202579TruAbutment DS, TruBaseNHASubstantially Equivalent
K201842TruBase SNHASubstantially Equivalent
K201197TruAbutment DS, TruBase SNHASubstantially Equivalent
K200817URIS OMNI Narrow System & ProstheticDZESubstantially Equivalent
K191913TruAbutment DSNHASubstantially Equivalent
K183106TruAbutment DSNHASubstantially Equivalent
K171532TruBase SNHASubstantially Equivalent
K172100URIS OMNI SystemDZESubstantially Equivalent
K172304TruAbutment DSNHASubstantially Equivalent
K170259TruAbutment DSNHASubstantially Equivalent
K152559TruAbutment DSNHASubstantially Equivalent

Registered establishments

FDA registered establishments for TruAbutment Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30124226933012422693TRUABUTMENT INC.17666 Fitch, Irvine, CA 92614 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1313-2025Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/ARetroactive: Due to defect and quality issues dental scanner may not scan properly/accuratelyClass IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain