AccessGUDID - DEVICE: JAZZ POLISHER (D69089117S32)

GUDID

Device Identifier (DI) Information

Brand Name: JAZZ POLISHER
Version or Model: U89117
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 89117S3
Company Name: Ss White Burs, Inc.

Primary DI Number: D69089117S32
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 151760014 *Terms of Use

Device Description: JAZZ RA ZIRCONIA/ALUMINA POLISHER 2 STEP ZA2S FINE FLAME-STERILE- 3 PACK

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):	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?
63517	Dental abrasive point, single-use	A sterile rotary endpiece designed to be attached to a dental power tool handpiece to perform a specific rotating mechanical function during a dental or orthodontic procedure, typically for polishing and smoothing natural or restorative dental materials (e.g., to finish a crown). Also referred to as a polisher, it is available in various forms [e.g., conical] and sizes and is made of synthetic polymer materials (e.g., silicone, rubber). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHL	POINT, ABRASIVE

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: Yes
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: ec529ee8-889d-43e4-bde9-7eea0db181df
Public Version Date: May 22, 2025
Public Version Number: 3
DI Record Publish Date: February 19, 2025

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: D69089117S30 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(732)905-1100
Email: customerservice@sswhitedental.com

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