AccessGUDID - DEVICE: Therapy Wafer (D746EB25M1)

GUDID

Device Identifier (DI) Information

Brand Name: Therapy Wafer
Version or Model: EB-25M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EB-25M
Company Name: DENTSPLY SIRONA ORTHODONTICS INC.

Primary DI Number: D746EB25M1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 116903307 *Terms of Use

Device Description: THERAPY WAFER - SCENTED MINT 25PK

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
44858	Bite relief pad	A thin, plastic, horshoe-like wafer that is placed between the upper and lower sets of teeth and bitten down on, or chewed, to help relieve pain or discomfort after orthodontic treatment. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECS	Pusher, Band, 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: c29795f6-7995-48fa-956e-160efd759fa7
Public Version Date: March 01, 2024
Public Version Number: 4
DI Record Publish Date: December 16, 2021

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: D746EB25M0 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: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(844)848-0137
Email: essix.sales@dentsplysirona.com

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