AccessGUDID - DEVICE: IPS e.max Press (DVIV626300EN1)

GUDID

Device Identifier (DI) Information

Brand Name: IPS e.max Press
Version or Model: 626300EN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 626300EN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DVIV626300EN1
Issuing Agency: HIBCC
Commercial Distribution End Date: January 27, 2022
Device Count: 50
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: IPS e.max Press HO 1 5 pcs, IPS e.max Press MO 1 5 pcs, IPS e.max Press LT A1 5 pcs., IPS e.max Press LT A2 5 pcs., IPS e.max Press LT A3 5 pcs., IPS e.max Press LT B1 5 pcs., IPS e.max Press HT A1 5 pcs, IPS e.max Press HT A2 5 pcs, IPS e.max Press HT A3 5 pcs, IPS e.max Press HT B1 5 pcs

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):	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?
44879	Dental implant suprastructure, permanent, preformed	A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
EIH	POWDER, PORCELAIN

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: 007fba69-9bf4-4efb-98c5-bc62ebcaf9eb
Public Version Date: January 28, 2022
Public Version Number: 2
DI Record Publish Date: November 11, 2020