FDA.reportPublic FDA data

Point Drill

Primary DI
08800070236871
Brand
Point Drill
Company
Izenimplant Co., Ltd.
Model
PDS3F20L
Published
2024-12-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
08800070236871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800070236871088000702368718800070236871

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
963328442
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
true
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
08800070250297Lab Driver SetLD4S2026-08-07
08800070230008ZENEX PLUS FixtureZPRM3510S2026-07-29
08800070201619ZENEX MULTI FixtureZMSR45202026-07-27
08800070218600ZENEX MULTI FixtureZMTR4520S2026-07-27
08800070218891ZENEX MULTI FixtureZMTR45202026-07-27
08800070223673Free Milling AbutmentFMARRH405092026-07-27
08800070223710Free Milling AbutmentFMARRH505082026-07-27
08800070223758Free Milling AbutmentFMARRH605082026-07-27
08800070223796Free Milling AbutmentFMARRH705082026-07-27
08800070224236Free Milling Abutment [Abutment + Screw]FMARRH40509S2026-07-27
08800070224274Free Milling Abutment [Abutment + Screw]FMARRH50508S2026-07-27
08800070224311Free Milling Abutment [Abutment + Screw]FMARRH60508S2026-07-27
08800070224359Free Milling Abutment [Abutment + Screw]FMARRH70508S2026-07-27
08800070228333ZENEX MULTI FixtureZMSR4520S2026-07-27
08800070248706Short DrillSD4F412026-07-27
08800070248713Short DrillSD4F452026-07-27
08800070248720Short DrillSD4F492026-07-27
08800070248737Short DrillSD4F532026-07-27
08800070248744Short DrillSD4F572026-07-27
08800070248751Short DrillSD4F662026-07-27

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