AccessGUDID - DEVICE: Telio Lab (DIVO628054EN1)

GUDID

Device Identifier (DI) Information

Brand Name: Telio Lab
Version or Model: 628054EN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 628054EN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO628054EN1
Issuing Agency: HIBCC
Commercial Distribution End Date: March 23, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: Telio Lab Cold Liquid OP0, OP1, Telio Lab Opaquer Liquid OP2, Telio Lab Opaquer BL3, A1, A2, A3, Telio Lab Dentin A3.5, B1, I1, I2, I3, N1, N2, N3, Telio Lab Incisal, Telio Lab Neck, SR Separating Fluid

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?
38781	Dental prosthesis veneer resin	A dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	CROWN AND BRIDGE, TEMPORARY, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 7635529e-9528-4d9d-90bf-5f3c3c82b09c
Public Version Date: March 23, 2021
Public Version Number: 2
DI Record Publish Date: September 27, 2018