FDA.reportPublic FDA data

DENTFLEX FIBER POST

Primary DI
00887919581772
Brand
DENTFLEX FIBER POST
Company
Peter Brasseler Holdings, LLC
Model
5013920U0
Catalog number
5013920U0
Device description
DFD16 DENTFLEX 16 DRILL 1P
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919581772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919581772008879195817728879195817720887919581772

GMDN Terms#

Term, Definition table
TermDefinition
Steel dental bur, reusableA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082080136
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919921608Brasseler USA5029442U05029442U02023-01-25
00887919504511Brasseler USA5008861U05008861U02022-12-01
00887919581611DENTFLEX FIBER POST5013908U05013908U02022-12-01
00887919581628DENTFLEX FIBER POST5013909U05013909U02022-12-01
00887919581635DENTFLEX FIBER POST5013910U05013910U02022-12-01
00887919581642DENTFLEX FIBER POST5013911U05013911U02022-12-01
00887919581659DENTFLEX FIBER POST5013912U05013912U02022-12-01
00887919581666DENTFLEX FIBER POST5013913U05013913U02022-12-01
00887919581673DENTFLEX FIBER POST5013914U05013914U02022-12-01
00887919581680DENTFLEX FIBER POST5013915U05013915U02022-12-01
00887919581697DENTFLEX FIBER POST5013916U05013916U02022-12-01
00887919581710DENTFLEX FIBER POST5013917U05013917U02022-12-01
00887919581734DENTFLEX FIBER POST5013918U05013918U02022-12-01
00887919581758DENTFLEX FIBER POST5013919U05013919U02022-12-01
08404535030853Brasseler USA5032379U05032379U02026-08-21
08404535030822Brasseler USA5032378U05032378U02026-07-13
00887919912125Brasseler USA5029292U05029292U02023-01-25
00887919752943Brasseler USA5025355U05025355U02026-07-27
00887919838074Brasseler USA5027336U05027336U02023-01-25
00887919711650Brasseler USA5024422U05024422U02026-06-19

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