FDA.reportPublic FDA data

VIVID POST TRANSLUCENT

Primary DI
08056099233111
Brand
VIVID POST TRANSLUCENT
Company
BIOLOREN SRL
Model
B16-0050
Device description
Cylindrical fiberglass light transmitting posts kit (20 posts and 4 drills).
Published
2024-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral
ELRPost, Root Canal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1
ELRPost, Root CanalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056099233111PrimaryGS10
18056099233118Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056099233111080560992331118056099233111
1805609923311818056099233118

GMDN Terms#

Term, Definition table
TermDefinition
Pin/post dental drill bitA shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
428561679
Device count
24
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056099233449VIVID POST DRILLB16-00602024-03-21
08056099233081VIVID POST WHITEB16-00202024-03-21
08056099233098VIVID POST WHITEB16-00302024-03-21
08056099233104VIVID POST TRANSLUCENTB16-00402024-03-21
18056099233446VIVID POST DRILLB16-00602024-03-21
08056099233128VIVID POST WHITE B16-00222023-08-01
08056099233135VIVID POST WHITE B16-00242023-08-01
08056099233142VIVID POST WHITE B16-00262023-08-01
08056099233159VIVID POST WHITEB16-00282023-08-01
08056099233166VIVID POST WHITEB16-00322023-08-01
08056099233173VIVID POST WHITEB16-00342023-08-01
08056099233180VIVID POST WHITE B16-00362023-08-01
08056099233197VIVID POST WHITEB16-00382023-08-01
08056099233203VIVID POST TRANSLUCENTB16-00422023-08-01
08056099233210VIVID POST TRANSLUCENTB16-00442023-08-01
08056099233227VIVID POST TRANSLUCENTB16-00462023-08-01
08056099233234VIVID POST TRANSLUCENTB16-00482023-08-01
08056099233241VIVID POST TRANSLUCENT B16-00522023-08-01
08056099233258VIVID POST TRANSLUCENTB16-00542023-08-01
08056099233265VIVID POST TRANSLUCENTB16-00562023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059224218007INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218014INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
06942686761223DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761230DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761247DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761254DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761261DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761278DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761285DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761292DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761308DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761315DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761322DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761339DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761346DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761353DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761360DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761377DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761384DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761391DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761407DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761414DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761421DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761438DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761445DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761452DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761469DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761476DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21