FDA.reportPublic FDA data

HAWK

Primary DI
08800017900025
Brand
HAWK
Company
DXM CO., LTD
Model
HD
Device description
Highest resolution 1280 x 720delivers precise, true-to-life imagesauto-focus system15 advanced LED lights for the correct color representation
Published
2023-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800017900025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017900025088000179000258800017900025

GMDN Terms#

Term, Definition table
TermDefinition
Intraoral cameraAn electro-optical device designed for image and/or video capture of the teeth and other intraoral anatomy, to assist with the diagnosis/management of dental/intraoral conditions (e.g., caries, plaque, calculus). It may be provided with specialized camera heads for specific types of examination (e.g., acquiring high resolution pictures/videos, emitting violet or infrared light), as well as camera holders and cables; it connects to an off-the-shelf computer (not included) for the power/processing/display.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688797315
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800017902395Fish Bone Bite TraysPosterior Side2026-08-25
08800017902401Fish Bone Bite TraysPosterior Sideless2026-08-25
08800017902418Fish Bone Bite TraysPosterior Half Side2026-08-25
08800017902425Fish Bone Bite TraysQuadrant2026-08-25
08800017902432Fish Bone Bite TraysAnterior2026-08-25
08800017900155DX-Ultra Ultrasonic IrrigationDX-UltraDXU-90002026-08-21
08800017902500DX-Ultra Ultrasonic IrrigationDisposable Plastic TipDXU-90102026-08-21
08800017902524EZ VPS Impression Transfer ConnectorsRibbon Holder2026-08-21
08800017902562EZ VPS Impression Transfer ConnectorsEZ-5100EZ-51002026-08-21
08800017902470FriendoPen TipFE-10042026-07-13
08800017902487Gutta EasyGun Tip 23 GuageGE-1004-23G2026-07-13
08800017902494Gutta EasyGun Tip 25 GuageGE-1004-25G2026-07-13
08800017901640CybirdULTRA2026-04-21
08800017902289EZ BITE BLOCK SOFT MOUTH PROP BBS-5000M2025-12-18
08800017902296EZ BITE BLOCK SOFT MOUTH PROP BBS-6000L2025-12-18
08800017902302EZ BITE BLOCK SOFT MOUTH PROP BBS-5000M2025-12-18
08800017902319EZ BITE BLOCK SOFT MOUTH PROP BBS-6000L2025-12-18
08800017901817EZ Bite blockBB-3000M2025-12-16
08800017900605EZ Bite blockBB-3000M2025-12-16
08800017902203DX-Mixer1802025-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
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J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-09-04
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
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J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
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