FDA.report

Brylic™ / W-98-18-BR-A200-GR

Primary DI
00842271129758
Brand
Brylic™ / W-98-18-BR-A200-GR
Company
SAGEMAX BIOCERAMICS, INC
Model
W-84016
Published
2017-03-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842271129758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842271129758008422711297588422711297580842271129758

GMDN Terms

TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Sterilization Methods

Method

Regulatory Flags

DUNS number
002265727
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00842271158680NexxZr Plus Multi 2.0 C1 W98-20mm7603892024-03-20
00842271158697NexxZr Plus Multi 2.0 C2 W98-20mm7603902024-03-20
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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
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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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