FDA.reportPublic FDA data

Neobiotech Implant System

Primary DI
08800394921460
Brand
Neobiotech Implant System
Company
Neobiotech. co., ltd
Model
BTMP55
Device description
Ø5.5
Published
2026-09-22
Public version status
New
Distribution status
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
08800394921460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800394921460088003949214608800394921460

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
688371566
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
08800394921170Neobiotech Implant SystemBTPCIB35022026-09-22
08800394921187Neobiotech Implant SystemBTPCIB35032026-09-22
08800394921194Neobiotech Implant SystemBTPCIB35042026-09-22
08800394921200Neobiotech Implant SystemBTPCIB48022026-09-22
08800394921217Neobiotech Implant SystemBTPCIB48032026-09-22
08800394921224Neobiotech Implant SystemBTPCIB48042026-09-22
08800394921231Neobiotech Implant SystemBTPCI3502C2026-09-22
08800394921248Neobiotech Implant SystemBTPCI3503C2026-09-22
08800394921255Neobiotech Implant SystemBTPCI3504C2026-09-22
08800394921262Neobiotech Implant SystemBTPCI4802C2026-09-22
08800394921279Neobiotech Implant SystemBTPCI4803C2026-09-22
08800394921286Neobiotech Implant SystemBTPCI4804C2026-09-22
08800394921293Neobiotech Implant SystemALXMAXY322026-09-22
08800394921309Neobiotech Implant SystemATD2528142026-09-22
08800394921316Neobiotech Implant SystemATSD2532082026-09-22
08800394921323Neobiotech Implant SystemATSD2532102026-09-22
08800394921330Neobiotech Implant SystemATSD2532122026-09-22
08800394921347Neobiotech Implant SystemATSD3235082026-09-22
08800394921354Neobiotech Implant SystemATSD3235102026-09-22
08800394921361Neobiotech Implant SystemATSD3542082026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800394921293Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921309Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921316Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921323Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921330Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921347Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921354Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921361Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921378Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921385Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921392Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921408Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921415Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921422Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921439Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921446Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921453Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921477Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
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