Home GUDID 00810060227206 Blue Sky Bio, LLC
Primary DI 00810060227206
Brand Blue Sky Bio, LLC
Company BLUE SKY BIO LLC
Model IJHTP4316
Device description Bio Max TP Implant 4.3 x 16 TAPER
Published 2026-04-22
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name DZE Implant, Endosseous, Root-Form
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DZE Implant, Endosseous, Root-Form Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810060227206 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810060227206 00810060227206 810060227206 0810060227206
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 618960848 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810060227060 Blue Sky Bio, LLC IJHTP3010 2026-04-22 00810060227077 Blue Sky Bio, LLC IJHTP3011 2026-04-22 00810060227084 Blue Sky Bio, LLC IJHTP3013 2026-04-22 00810060227091 Blue Sky Bio, LLC IJHTP3016 2026-04-22 00810060227107 Blue Sky Bio, LLC IJHTP3508 2026-04-22 00810060227114 Blue Sky Bio, LLC IJHTP3510 2026-04-22 00810060227121 Blue Sky Bio, LLC IJHTP3511 2026-04-22 00810060227138 Blue Sky Bio, LLC IJHTP3513 2026-04-22 00810060227145 Blue Sky Bio, LLC IJHTP3516 2026-04-22 00810060227152 Blue Sky Bio, LLC IJHTP4306 2026-04-22 00810060227169 Blue Sky Bio, LLC IJHTP4308 2026-04-22 00810060227176 Blue Sky Bio, LLC IJHTP4310 2026-04-22 00810060227183 Blue Sky Bio, LLC IJHTP4311 2026-04-22 00810060227190 Blue Sky Bio, LLC IJHTP4313 2026-04-22 00810060227213 Blue Sky Bio, LLC IJHTP5006 2026-04-22 00810060227220 Blue Sky Bio, LLC IJHTP5008 2026-04-22 00810060227237 Blue Sky Bio, LLC IJHTP5010 2026-04-22 00810060227244 Blue Sky Bio, LLC IJHTP5011 2026-04-22 00810060227251 Blue Sky Bio, LLC IJHTP5013 2026-04-22 00810060227268 Blue Sky Bio, LLC IJHTP5016 2026-04-22
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