AccessGUDID - DEVICE: UltraCal XS (00883205033253)

GUDID

Device Identifier (DI) Information

Brand Name: UltraCal XS
Version or Model: 5145
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5145
Company Name: ULTRADENT PRODUCTS, INC.

Primary DI Number: 00883205033253
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013369913 *Terms of Use

Device Description: UltraCal XS Refill

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?
47232	Calcium hydroxide dental suspension	A very basic (high pH) calcium hydroxide (Ca(OH)2) solution (also known as slaked lime or milk of lime) intended to be used in dentistry for a variety of purposes including to flush and disinfect root canals and crowns/bridges before final insertion, and to change the viscosity and/or moisten a temporary tooth filling material. It may also encourage the change of fibroblasts (cells which form the connective tissue of the body) into odontoblast-like cells to produce reparative dentine. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIF	Resin, Root Canal Filling

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211905	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
Storage Environment Temperature: between 2 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3f6ceefa-5d67-4c43-becc-3fe84719d8ed
Public Version Date: June 26, 2023
Public Version Number: 1
DI Record Publish Date: June 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: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 801-572-4200
Email: customerservice@ultradent.com

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