FDA.reportPublic FDA data

Blue Sky Bio, LLC

Primary DI
00810060222324
Brand
Blue Sky Bio, LLC
Company
BLUE SKY BIO LLC
Model
MSQN
Device description
BIO | Quattro Implant Impression Transfer NP
Published
2021-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EHYTray, Impression, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060222324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060222324008100602223248100602223240810060222324

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
618960848
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
false
Expiration date on label
false
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
00810060227046Blue Sky Bio, LLC.BDSJH2026-02-10
00810060226933Blue Sky Bio, LLC.HHS3565502025-10-16
00810060226940Blue Sky Bio, LLC.HHS3565702025-10-16
00810060226834Blue Sky Bio, LLC.GDT-USP2025-07-25
00810060226841Blue Sky Bio, LLC.GDT-UMP2025-07-25
00810060226858Blue Sky Bio, LLC.GDT-ULP2025-07-25
00810060226865Blue Sky Bio, LLC.GDT-LSP2025-07-25
00810060226872Blue Sky Bio, LLC.GDT-LMP2025-07-25
00810060226889Blue Sky Bio, LLC.GDT-LLP2025-07-25
00810060226629Blue Sky Bio, LLC. HSSQN38302025-07-23
00810060226636Blue Sky Bio, LLC.HSSQN38502025-07-23
00810060226643Blue Sky Bio, LLC.HSSQN38702025-07-23
00810060226650Blue Sky Bio, LLC.HSSQN48302025-07-23
00810060226667Blue Sky Bio, LLC.HSSQN48502025-07-23
00810060226674Blue Sky Bio, LLC.HSSQN48702025-07-23
00810060226681Blue Sky Bio, LLC.HSSQN65302025-07-23
00810060226698Blue Sky Bio, LLC.HSSQN65502025-07-23
00810060226704Blue Sky Bio, LLC.HSSQN65702025-07-23
00810060226711Blue Sky Bio, LLC.HSSQR38302025-07-23
00810060226728Blue Sky Bio, LLC.HSSQR38502025-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E241VT0220Cavex Bleach Transparent 1,0 mmCavex Holland B.V.EHY2026-03-10
28906139322081Taglus Impression TrayLAXMI DENTAL LIMITEDEHY2026-01-09
00723896030295ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030325ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030356ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030387ECOsply™ Biodegradable Disposable Impression Trays Medium Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030417ECOsply™ Biodegradable Disposable Impression Trays Small Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030448ECOsply™ Biodegradable Disposable Impression Trays Small Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030479ECOsply™ Biodegradable Disposable Impression Trays Quadrant UR/LL 10/PackPRACTICON, INC.EHY2026-01-08
00723896030509ECOsply™ Biodegradable Disposable Impression Trays Quadrant UL/LR 10/PackPRACTICON, INC.EHY2026-01-08
00723896030530ECOsply™ Biodegradable Disposable Impression Trays Anterior Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030561ECOsply™ Biodegradable Disposable Impression Trays Anterior Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030592ECOsply™ Biodegradable Disposable Impression Trays Assortment 10/PackPRACTICON, INC.EHY2026-01-08
00817169023890Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEHY2025-12-16
06977979289856AiditeAidite (Qinhuangdao) Technology Co., Ltd.EHY2025-11-17
06978447935008AiditeAidite (Qinhuangdao) Technology Co., Ltd.EHY2025-11-17
06978447938504AiditeAidite (Qinhuangdao) Technology Co., Ltd.EHY2025-11-17
10190707193192Redi-Lock™Ortho Organizers, Inc.EHY2025-10-23
10190707193208Redi-Lock™Ortho Organizers, Inc.EHY2025-10-23
10190707110786DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110793DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110809DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110816DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110823DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110830DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110847DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110854DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110861DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110878DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110885DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25