FDA.reportPublic FDA data

Invisalign

Primary DI
00816063020011
Brand
Invisalign
Company
Align Technology, Inc.
Model
1011
Device description
Invisalign Retainer
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DYTMaintainer, Space Preformed, Orthodontic
DYWBracket, Plastic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYTMaintainer, Space Preformed, OrthodonticDental1
DYWBracket, Plastic, OrthodonticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816063020011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816063020011008160630200118160630200110816063020011

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic teeth positioner, preformedA prefabricated dental device, typically made of plastic, that is an impression of a perfected bite used to prevent a patient's teeth from shifting position, or to move teeth to a final position, after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013831768
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816063023791Cleaning Crystals, Packette2272872026-07-21
00816063021506Kit, Pliers Set Detail/Eraser760182022-12-06
00816063020097Realine85542016-09-24
00816063020240The Signature Smile90162017-11-10
00816063020448Invisalign Signature Smile90212018-06-15
00816063020455Invisalign Signature Plus Smile90202018-06-15
00816063020462Invisalign Deluxe Smile90192018-06-15
00816063023029iTero Element™ 5D imaging system2176182026-07-22
00816063022312iTero Lumina Pro DOA2219592026-06-25
00816063021735iTero Element 5D scanning unit, service2069552026-06-23
00816063022169Attachment Template1000122023-07-24
00816063023180Invisalign ART90502026-02-25
00816063023777Invisalign Specifix Attachment System50352026-02-09
00816063023784lnvisalign Specifix Attachment System (include Engagement Features)50362026-02-09
00816063023760Gumlines2267972026-01-01
00816063023173iTero Lumina – PC cfg, Interface Box2176222025-09-16
00816063023197iTero Lumina Software2259692025-09-16
00816063023210iTero Lumina – PC cfg2231122025-09-16
00816063023227iTero Lumina – PC cfg2231102025-09-16
00816063023241iTero Lumina – PC cfg2231112025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D82944S01520300051Premium LineEC Certification Service GmbHDYW2026-07-30
D82944S01520300101Premium LineEC Certification Service GmbHDYW2026-07-30
D829480001C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480002C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480003C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480005C1Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001600000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001600000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001600000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001700000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001700000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001700000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001800000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001800000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001800000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001901000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001901000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001901000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002001000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002001000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002001000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002701000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002701000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002701000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002801000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002801000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002801000501Premium LineEC Certification Service GmbHDYW2026-07-30