AccessGUDID - DEVICE: Arcad Aligners (00860011071921)

GUDID

Device Identifier (DI) Information

Brand Name: Arcad Aligners
Version or Model: Clear Orthodontic Aligners
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ARCADLAB

Primary DI Number: 00860011071921
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080230996 *Terms of Use

Device Description: Top and Bottom Aligners

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44732	Orthodontic aligner auxiliary attachment kit	A collection of devices, used with retainer-style orthodontic appliances (e.g., preformed teeth aligners) to further facilitate and enhance teeth alignment. The kit includes buttons and elastics, typically made of clear materials for aesthetic purposes, that are attached to the orthodontic aligner and/or teeth to help achieve extrusion, rotation and anchorage control. This provides the clinician with greater control to achieve additional tooth movement during the treatment. The contents of this kit may also include plastic/composite adhesive, etchant, elastics, burs and polishing wheels for cutting the aligners. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PNN	Orthodontic software
NXC	Aligner, sequential

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192244	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 67d424b8-18c2-4950-a826-6542efdf77de
Public Version Date: November 27, 2023
Public Version Number: 1
DI Record Publish Date: November 17, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: Yes CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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