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

Carrollton, TX, US

BRIUS Technologies Inc. appears in FDA device records in Carrollton, TX. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
3
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for BRIUS Technologies Inc. in 2021.

Clearances by year, as a table
510(k) clearance decisions for BRIUS Technologies Inc., by decision year
YearClearances
20212
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K212828BRIUS Planner SoftwarePNNSubstantially Equivalent
K202792BRIUS Clear AlignersNXCSubstantially Equivalent

Registered establishments

FDA registered establishments for BRIUS Technologies Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30146809243014680924BRIUS Technologies Inc.2611 Westgrove Drive, Carrollton, TX 75006 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-0890-2022Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400ULPontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.Class IITerminated
Z-0889-2022Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400ULPontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.Class IITerminated
Z-0888-2022Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400ULPontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.Class IITerminated

Verification record

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