AccessGUDID - DEVICE: Hawley Retainer with Circumferential Clasps (D775AHCC0)

GUDID

Device Identifier (DI) Information

Brand Name: Hawley Retainer with Circumferential Clasps
Version or Model: AHCC
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Great Lakes Dental Technologies, Ltd.

Primary DI Number: D775AHCC0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041854332 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
35310	Orthodontic retainer	An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYJ	Retainer, Screw Expansion, Orthodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: b4b46f49-102e-45a3-9477-525891ddb0bc
Public Version Date: May 18, 2026
Public Version Number: 1
DI Record Publish Date: May 10, 2026