AccessGUDID - DEVICE: Empower Clear (00190746154591)

GUDID

Device Identifier (DI) Information

Brand Name: Empower Clear
Version or Model: 1485-22-3417
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1485-22-3417
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746154591
Issuing Agency: GS1
Commercial Distribution End Date: March 23, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: COSMETIC SL EMPOWER CLEAR INTERACT LL 1ST BIC 022 T-17 A=0 R=0

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	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?
58818	Self-ligating orthodontic bracket	A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It has an integral fixation clip, typically made of a polymer with a metal hinge, to retain the archwire (self-ligating) within a metal insert slot. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJM	Bracket, Ceramic, Orthodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122753	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: 1831e373-9708-49ee-9dc7-3a120976500c
Public Version Date: March 23, 2026
Public Version Number: 5
DI Record Publish Date: March 12, 2020