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

San Jose, CA, US

Align Technology, Inc. appears in FDA device records in San Jose, CA. FDA records list 15 510(k) clearances between and , no PMA records and 2 registered establishments. 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
15
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 15 510(k) clearances for Align Technology, Inc. between 1998 and 2026. The busiest year on record is 2025, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Align Technology, Inc., by decision year
YearClearances
19981
20081
20151
20181
20201
20222
20232
20242
20253
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261847iTero Lumina™ ProNTKSubstantially Equivalent
K252931Invisalign® Palatal Expander SystemNXCSubstantially Equivalent
K252870Invisalign Specifix Attachment SystemNXCSubstantially Equivalent
K252380Invisalign SystemNXCSubstantially Equivalent
K240573iTero Lumina™ ProNTKSubstantially Equivalent
K241412Invisalign SystemNXCSubstantially Equivalent
K232887Invisalign Palatal Expander SystemNXCSubstantially Equivalent
K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksNXCSubstantially Equivalent
K222894Invisalign System, Pre-Formed Attachment SystemNXCSubstantially Equivalent
K220287Invisalign SystemNXCSubstantially Equivalent
K193659iTero Element 5DNTKSubstantially Equivalent
K181739Invisalign System with Mandibular Advancement FeatureNXCSubstantially Equivalent
K143630Invisalign SystemNXCSubstantially Equivalent
K081960INVISALIGN SYSTEMNXCSubstantially Equivalent
K981095ALIGN SYSTEMNXCSubstantially Equivalent

Registered establishments

FDA registered establishments for Align Technology, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
29537493002519584Align Technology, Inc.2820 Orchard Parkway, San Jose, CA 95134 US2026and 4 more, listed in full below
30096469993009646999Align Technology, Ltd.1 Yitzhak Rabin Rd., Petach Tikva Central 4925110 IL2026

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-1017-2023Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 90013D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.Class IICompleted

Verification record

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