AccessGUDID - DEVICE: Ti-Core Flow Plus (00766054000051)

GUDID

Device Identifier (DI) Information

Brand Name: Ti-Core Flow Plus
Version or Model: 832-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 832-00
Company Name: ESSENTIAL DENTAL SYSTEMS, INC.

Primary DI Number: 00766054000051
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101147171 *Terms of Use

Device Description: Core Material and Post Cement Syrangeable Dual Cure Natural Shade A2

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?
47906	Custom-made dental composite resin kit	A collection of customized equipment and supplies intended to be used to apply/polymerize composite resins to fill dental cavities or restore damaged dental tissue. It includes the composite resin, which may be self-, light-, or dual-cured, and additional devices which typically include a dental syringe, a mixing palette, a mixing pad, and brushes; it is customized for a specific patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	CEMENT, DENTAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101504	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 60 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Two - 9.5 gram dual barrel syringes

Device Record Status

Public Device Record Key: 5c2fc597-dfc4-4ec9-ac98-de22238f13c7
Public Version Date: November 22, 2023
Public Version Number: 4
DI Record Publish Date: July 01, 2016

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

Customer Contact

[?]

Phone: +1(201)487-9090
Email: udi@edsdental.com

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