FDA.report

IPS e.max Press

Primary DI
DIVO745006EN0
Brand
IPS e.max Press
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
745006EN
Catalog number
745006EN
Device description
IPS e.max Ceram Transpa Incisal 20 g 1, IPS e.max Press LT A2 5 Stk., IPS e.max Press HT A2 5 Stk., IPS e.max Press Multi A2 5 Stk., IPS Ivocolor Essence 1.8g E04 sunset, IPS Ivocolor Shade Dentin 3g SD2, IPS Ivocolor Shade Incisal 3g SI1, IPS Ivocolor Glaze Powder FLUO 1.8g, IPS Ivocolor Mix Liq allround 15ml, IPS e.max Press MT A2 5 Stk.
Published
2020-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
DIVO745006EN1PrimaryHIBCC0
DIVO745006EN0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental implant suprastructure, permanent, preformedA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
448015938
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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