FDA.reportPublic FDA data

WOODPECKER,DTE

Primary DI
06944843604695
Brand
WOODPECKER,DTE
Company
Guilin Woodpecker Medical Instrument Co., Ltd.
Model
YZ-1L
Device description
Ultrasonic dental scaling/debridement system handpiece
Published
2021-08-28
Public version status
Update
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053555000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053555000ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-LGuilin Woodpecker Medical Instrument Co., Ltd.2006-08-21ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944843604695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944843604695069448436046956944843604695

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpieceA hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.

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
04589551395088Multi Pad2NAKANISHI INC.EBW2026-06-02
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
08809260475403AHP-85-SSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475410TRAUSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475359SDI10Saeshin Precision Co., Ltd.EBW2026-03-04
10194665008444A-decA-DEC, INC.EBW2026-02-19
10194665008475A-decA-DEC, INC.EBW2026-02-19
10194665008482A-decA-DEC, INC.EBW2026-02-19
10194665008499A-decA-DEC, INC.EBW2026-02-19
10194665008505A-decA-DEC, INC.EBW2026-02-19
10194665008512A-decA-DEC, INC.EBW2026-02-19
10194665008529A-decA-DEC, INC.EBW2026-02-19
10194665008550A-decA-DEC, INC.EBW2026-02-19
E27668312130Midwest Motor Control ModuleSIRONA Dental Systems GmbHEBW2026-02-17
E27668302980Midwest Power Lux Implant MotorSIRONA Dental Systems GmbHEBW2026-02-13
E27668303060Midwest Power Lux MotorSIRONA Dental Systems GmbHEBW2026-02-13
00810126043153SM7 US ( Complete Set )HIOSSEN, INC.EBW2026-01-09
00810126043160S200EML (Contra) Dental Surgery Hand PieceHIOSSEN, INC.EBW2026-01-09
08404535021684ForzaPeter Brasseler Holdings, LLCEBW2026-01-09
08404535021714ForzaPeter Brasseler Holdings, LLCEBW2026-01-09
04589551393381Straumann SGL80MNAKANISHI INC.EBW2026-01-03
04589551393374Straumann Surgical Motor Pro 2NAKANISHI INC.EBW2026-01-03
04589551384082Straumann SGL80MNAKANISHI INC.EBW2026-01-03
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2025-12-18