FDA.reportPublic FDA data

WOODPECKER

Primary DI
06944843605173
Brand
WOODPECKER
Company
Guilin Woodpecker Medical Instrument Co., Ltd.
Model
MT2
Device description
Dental delivery system instrument unit, electric
Published
2022-08-15
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
EBWController, Foot, Handpiece And Cord
EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203706000Dental Electric MotorGuilin Woodpecker Medical Instrument Co., Ltd.2022-01-13EBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944843605173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944843605173069448436051736944843605173

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system instrument unit, electricA mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
545272577
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944843604473DTED-Laser 162026-04-15
06944843604480DTED-Laser Blue2026-04-15
06944843611839WOODPECKERAi Ray 2026-04-15
06944843617169WOODPECKERLaser Smart2026-04-15
06944843617176WOODPECKERLaser Smart Blue2026-04-15
06944843655925WOODPECKERAi Ray Pro2026-04-15
06944843659794WOODPECKERMaster Ray2026-04-15
06944843660936WOODPECKERAi Ray Lite2026-04-15
06944843611587woodpeckerAP-A2024-10-18
06944843611594DTEAP-A2024-10-18
06944843611600woodpeckerAP-B2024-10-18
06944843611617DTEAP-B2024-10-18
06944843655987DTEPT-B2024-10-18
06944843658155woodpeckerV V Light2024-10-18
06944843658728DTELED.B2024-10-18
06944843616872LOVE HYGIENELove Hygiene Air2024-08-09
06944843655024WOODPECKERPT-B2024-06-20
06944843610054WOODPECKER,DTEX-Cure2021-08-26
06944843605715WOODPECKERi Led II2021-08-25
06944843605722DTEi Led II2021-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
10304040196974Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
10304040196981Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
08033837935889AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935896AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935902Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935919Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935926CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935933CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08809260475519X-CUBESaeshin Precision Co., Ltd.EBW2026-04-02
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
08809260475403AHP-85-SSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475410TRAUSSaeshin Precision Co., Ltd.EBW2026-03-25
10686864060946MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864060953MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10194665008444A-decA-DEC, INC.EBW2026-02-19
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHEBW2025-12-18
10686864061141MEDICOM DENTICAREAMD Medicom IncEGS2025-03-18
10686864060915MEDICOM DENTICARE SWIVEL DPA, SOFT CUPAMD Medicom IncEGS2024-09-27
10686864060922MEDICOM DENTICARE SWIVEL DPA, FIRM CUPAMD Medicom IncEGS2024-09-27
10686864060939MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSHAMD Medicom IncEGS2024-09-27
00302730002911YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002928YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002935YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002690YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2023-07-27
00302730002706YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2023-07-27