FDA.reportPublic FDA data

Wax Disc / Z-95-25-WD-BL00-SD

Primary DI
00842271163769
Brand
Wax Disc / Z-95-25-WD-BL00-SD
Company
SAGEMAX BIOCERAMICS, INC
Model
Z-61005
Published
2019-10-21
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

Product Codes#

Code, Name table
CodeName
EGDWax, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842271163769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842271163769008422711637698422711637690842271163769

GMDN Terms#

Term, Definition table
TermDefinition
Wax dental impression materialA material made of wax, sometimes in combination with resins of low melting point, designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002265727
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842271158666NexxZr Plus Multi 2.0 B3 W98-20mm7603872024-03-20
00842271158673NexxZr Plus Multi 2.0 B4 W98-20mm7603882024-03-20
00842271158680NexxZr Plus Multi 2.0 C1 W98-20mm7603892024-03-20
00842271158697NexxZr Plus Multi 2.0 C2 W98-20mm7603902024-03-20
00842271158703NexxZr Plus Multi 2.0 C3 W98-20mm7603912024-03-20
00842271158710NexxZr Plus Multi 2.0 C4 W98-20mm7603922024-03-20
00842271158727NexxZr Plus Multi 2.0 D2 W98-20mm7603932024-03-20
00842271158734NexxZr Plus Multi 2.0 D3 W98-20mm7603942024-03-20
00842271158741NexxZr Plus Multi 2.0 D4 W98-20mm7603952024-03-20
00842271158192NexxZr Plus Multi 2.0 A1 W98-14mm7603402024-03-19
00842271158208NexxZr Plus Multi 2.0 A2 W98-14mm7603412024-03-19
00842271158215NexxZr Plus Multi 2.0 A3 W98-14mm7603422024-03-19
00842271158222NexxZr Plus Multi 2.0 A3.5 W98-14mm7603432024-03-19
00842271158239NexxZr Plus Multi 2.0 A4 W98-14mm7603442024-03-19
00842271158246NexxZr Plus Multi 2.0 B1 W98-14mm7603452024-03-19
00842271158253NexxZr Plus Multi 2.0 B2 W98-14mm7603462024-03-19
00842271158260NexxZr Plus Multi 2.0 B3 W98-14mm7603472024-03-19
00842271158277NexxZr Plus Multi 2.0 B4 W98-14mm7603482024-03-19
00842271158284NexxZr Plus Multi 2.0 C1 W98-14mm7603492024-03-19
00842271158291NexxZr Plus Multi 2.0 C2 W98-14mm7603502024-03-19

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