K Number
K211358
Device Name
Implanter incl. Accessories
Date Cleared
2022-11-21

(567 days)

Product Code
Regulation Number
872.4200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
Device Description
The Implanter is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. The submission consists of: - the control unit - a motor with cable with light (sterilizable: SPM58L) - a wired foot control (MF4) - and as an attachment the surgical contra-angle handpieces (with LED:WP-1L/without LED:WP-1). Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display. The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning. The control unit is intended to be used with the motor SPM58L. To run the Implanter according to its intended use, Guilin Woodpecker provides two different surgical handpieces.
More Information

No
The summary describes a mechanical device with pre-set programs and user-defined modes, controlled by foot or touch. There is no mention of AI, ML, image processing, or data training/testing, which are typical indicators of AI/ML technology in medical devices.

Yes
The device is used for "treatment of dental hard tissue" in dental surgery, implantology, and maxillofacial surgery, which directly relates to health and medical purposes.

No

The device is a mechanical drive unit for performing dental surgical procedures like drilling and implanting, not for diagnosing conditions.

No

The device description explicitly lists hardware components such as a control unit, motor with cable, wired foot control, and surgical contra-angle handpieces. While it mentions software validation, it is part of a larger system that includes physical hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "treatment of dental hard tissue" in dental surgery, implantology, and maxillofacial surgery. This describes a surgical tool used directly on the patient's body.
  • Device Description: The description details a mechanical drive unit, motor, foot control, and handpieces. These are all components of a surgical system, not a device used to examine specimens from the human body.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.

IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical instrument used on the human body.

N/A

Intended Use / Indications for Use

Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.

Product codes

EBW

Device Description

The Implanter is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.

The submission consists of:

  • the control unit
  • a motor with cable with light (sterilizable: SPM58L)
  • a wired foot control (MF4)
  • and as an attachment the surgical contra-angle handpieces (with LED:WP-1L/without LED:WP-1)

Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display.

The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning.

The control unit is intended to be used with the motor SPM58L.

To run the Implanter according to its intended use, Guilin Woodpecker provides two different surgical handpieces.

TypeTransmission ratioMax. speedMax. torque
WP-1L20:140,00080 Ncm
WP-120:140,00080 Ncm

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Dental hard tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental practice, dental clinic

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

To verify the performance requirements of the proposed device, the following tests were performed in accordance with listed standards and FDA guidance documents. Testing results demonstrate substantial equivalence.

  • To verify the conformity of the proposed device with the requirements of IEC 60601-1:(Medical electrical equipment Part 1: General requirements for basic safety and essential performance).
  • To verify the conformity of the proposed device with the requirements of IEC 60601-1-2:(Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromaqnetic compatibility).
  • To verify the handpiece function and lifecycle according to ISO 14457:2017: (Dentistry-Handpieces and Motors).
  • To validate the proposed device's software and its foot control's software respectively in conformity with IEC 62304 (Medical device software - Software lifecycle processes) and FDA Guidance titled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for a MODERATE level of concern.
  • To verify the thermal safety in conformity with the standard IEC 62471:2004: (Photobiological safety of lamps and lamp systems).
  • To evaluate the biocompatibility of patient contacting components of the proposed device according to the requirements ISO 10993-1 (Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process), ISO 10993-5 (Biological evaluation of medical devices Part 5: Test for cytotoxicity), ISO 10993-10 ( Biological evaluation of medical devices - Part 10: Tests for skin sensitization ) and ISO 7405 (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry).
  • To verify the conformity of the proposed device with the requirements of IEC 60601-1-2:(Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic compatibility) and IEC 60601-1-1 (Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems).
  • To validate the reprocessing (Cleaning, Sterilization) according to FDA Guidance titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling -Guidance for Industry and Food and Drug Administration Staff,"
  • To verify the conformity of the proposed device with the requirements of FDA Guidance on Dental Handpieces titled "Dental Handpieces – Premarket Notification [510(k)] Submissions.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K161957

Reference Device(s)

K052741

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 21, 2022

Guilin Woodpecker Medical Instrument Co., Ltd. % Fu Ailing Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Liuxian Avenue, Xili Town Nashan District Shenzhen, Guangdong 518055 CHINA

Re: K211358

Trade/Device Name: Implanter incl. Accessories Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EBW Dated: October 25, 2022 Received: October 25, 2022

Dear Fu Ailing:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K211358

Device Name Implanter incl. Accessories

Indications for Use (Describe)

Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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3

Version:A/0

Product: Implanter

510(k) Summary — K211358

This 510(k) Summary is submitted according to the requirements of 21 CFR §807.92.

5.1 Administrative Information

Date Summary preparedNovember 17, 2022
Manufacturer informationSubmitter's Name: Guilin Woodpecker Medical Instrument
Co., Ltd.
Address: Information Industrial Park, Guilin National High-
Tech Zone, Guilin, Guangxi, 541004, P.R. China
Contact person: Yang Yunfeng
TEL: +86-773-2350532
FAX: +86-773-5822450
Mail: ipr@glwoodpecker.com
Submission CorrespondentCompany Name: Shenzhen Joyantech Consulting Co., Ltd.
Address: Room 1713A, 17 Floor, Block A, Zhongguan Times
Square, Liuxian Avenue, Xili Town, Nanshan
District, Shenzhen, Guangdong, 518055, China
Contact person: Ms. Fu Ailing
E-Mail: aileen@cefda.com
Image: [Logo]
Establishment registration
number3005581016

5.2 Device Information

Type of 510(k) submission:Traditional
Common Name:Controller, Foot, Handpiece and Cord
Trade Name:Implanter incl. Accessories
Model:Implanter
Classification name:Dental Handpiece and Accessories

4

Product: Implanter

Version:A/0

Review Panel:Dental
Product Code:EBW
Device Class:I
Regulation Number:21 CFR 872.4200

5.3 Predicate Device

Predicate Device

Sponsor:W&H DENTALWERK BÜRMOOS GMBH
Device:Implantmed SI-1015 incl. Accessories
510(K) Number:K161957

Reference Device

Sponsor:W&H Dentalwerk Buermoos GmbH
Device:ImplantMED SI-915 (115V Version) ImplantMED SI-923
(230V Version) Incl. Accessories
510(K) Number:K052741

5.4 Device Description

The Implanter is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.

The submission consists of:

  • the control unit
  • a motor with cable with light (sterilizable: SPM58L)
  • a wired foot control (MF4)
  • and as an attachment the surgical contra-angle handpieces (with LED:WP-1L/without LED:WP-1)

5

Guilin Woodpecker009_510(k) Summary
Product: ImplanterVersion: A/0

Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display.

The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning.

The control unit is intended to be used with the motor SPM58L.

To run the Implanter according to its intended use, Guilin Woodpecker provides two different surgical handpieces.

TypeTransmission ratioMax. speedMax. torque
WP-1L20:140,00080 Ncm
WP-120:140,00080 Ncm

5.5 Indications for Use

lmplanter (incl.SPM58L):

Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.

5.6 Indication for Use and Technological Characteristics of the Subject Device Compared to the Predicate Device

6

Table 1 Comparison of Indications for Use and Technological Characteristics Between the Subject Device and the Predicate Device

General Specification Implanter incl. Accessories
IDComparison
ItemProposed Device
Implanter incl.
AccessoriesPredicate Device
Implantmed SI-1015
incl. Accessories
K161957Reference Device
ImplantMED SI-915 (115V
Version) ImplantMED SI-
923 (230V Version) Incl.
Accessories
K052741Difference Between the
Proposed Device and the
Predicate Device
1PictureImage: Proposed Device Implanter incl. AccessoriesImage: Predicate Device Implantmed SI-1015 incl. Accessories K161957Image: Reference Device ImplantMED SI-915 (115V Version) ImplantMED SI-923 (230V Version) Incl. Accessories K052741-
2NameImplanterImplantmed SI-1015Implantmed SI-915/923-
3ManufacturerGuilin Woodpecker
Medical Instrument Co.,
Ltd.W&H Dentalwerk
Bürmoos GmbHW&H Dentalwerk Bürmoos
GmbH-
Product: ImplanterVersion:A/0
4Where UsedDental practice, dental clinicDental practice, dental clinicDental practice, dental clinicNone
5Indication for UseMechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964 (Din 13.940) The equipment is a drive unit for use in dental surgery, implantology and maxilla-facial surgery for treatment of dental hard tissue.None
6Control UnitMain dimensions:
276x267x110 mm

Front panel:
Display with capacitive touch

Programs:
8 programs for various | Main dimensions:
100x262x291 mm

Front panel:
Display with capacitive touch

Programs:
5 programs for various | Main dimensions:
90x252x254mm

Front panel:
Graphical display without backlighting

Programs:
5 programs for various | Yes.
For Guilin Woodpecker Medical Instrument Co., Ltd., there are 8 programs:

  1. Positioning,
  2. Hole-drilling,
  3. Hole-Broadening,
  4. Tapping, | |

7

009_510(k) Summary

8

Product: ImplanterVersion:A/
stages of implantologystages of implantologystages of implantology5. Implanting,
Irrigation:Irrigation:Irrigation:6. Lock the abutment screw,
110ml/min.100ml/min.100ml/min.7. User defined Mode,
8. Cleaning
For W&H Dentalwerk Bürmoos
GmbH, there are
Irrigation Tubing can be
inserted ergonomically on
the unit's side faceIrrigation Tubing can be
inserted ergonomically on
the unit's side faceIrrigation Tubing can be
inserted on the unit's front
face5 programs:
Drill function,
Drill function,
Drill function,
Thread-cutter function,
Implant insertion. Similar
functions include:
2 vs a or b or c;
4 vs d;
5 vs e.
The additional programs
included for the proposed
device include 1,3,6,7 and 8.
1 – Includes set ranges of
speed and torque for
positioning of implant
placement.
Product: ImplanterVersion:A/C
3 – Includes set ranges of
speed and torque for hole-
broadening procedures.
6 – Includes set ranges of
speed and torque for
placement of the abutment
screw.
7 – User defined mode for
use with a straight handpiece
with ball drill bit.
8 – Used to adjust the water
capacity.
Differences between
functions are supported by
performance testing.
7Foot ControlMain dimension:
249.7x181.7x160.8

Features:
4 buttons for pump on/off
Forward/reverse
Change programs | Main dimension:
154x202x210

Features:
4 buttons for pump on/off
Forward/reverse
Change programs | Main dimension:
215x190x40 (without
cable)

Features:
4 buttons for pump on/off
Forward/reverse
Change programs | Yes. The power supply of
the proposed device is
performed via wired foot
control not via
wireless control. The
reference device also
includes a wired foot
control. | |
| Product: Implanter | | | | | | Version:A/0 |
| | | Motor control (on/off and variable) | Motor control (on/off and variable) | Motor control (on/off and variable) | | |
| | | Power supply:
Wired
Via cable | Power supply:
Wireless
Via 3xAA batteries | Power supply:
wired
via cable | | |
| 8 | Motor with
Cable | Length:
110 mm
With LED contacts
without LED contacts | Length:
71.65 mm
With LED contacts | Length:
75 mm
Without LED contacts | Yes. The motor is with LED
contacts or without LED
contacts. The predicate
device includes LED
contacts and the reference
device includes no LED
contacts. | |
| 9 | Module | / | W&H SI-SQ:
Connection via USB-
cable | Osstell ISQ:
Stand-alone device | Yes. The proposed device
does not include a module.
However, performance
testing has been included
demonstrating its use. | |

9

10

11

009_510(k) Summary

| Version:A/

Product: Implanter
Technical Data/Functions Implanter incl. Accessories
IDComparison
ItemProposed Device
Implanter incl.
AccessoriesPredicate Device
Implantmed SI-1015
incl. AccessoriesReference Device
ImplantMED SI-915 (115V
Version) ImplantMED SI-
923 (230V Version) Incl.
AccessoriesDifference Between the
Proposed Device and the
Predicate Device
10Max.
Mechanical
output power120 W80 W70 WYes. Due to different design
scheme, the proposed
device has the higher
power, but this does not
lead to any negative effect
regarding substantial
equivalence because of the
constructive power
reserves of the motor (no
big difference between
5.5 Ncm - 6.2 Ncm for the
motor).
11Torque at the
motor5.5 Ncm6.2 Ncm5.5 NcmYes. The proposed device
offers a lower maximum
level of torque output at the
motor: 5.5 Ncm. However,
this is in alignment with the
reference device.
Version:A/0
Product: Implanter
12Speed range
of motor300 - 40,000 rpm200 - 40,000 rpm200 - 40,000 rpmNone
13Supply
voltage100-120 VAC100-130 VAC100-130 VACNone
14Rated
current1.5-2 A0.3-1.6 A0.2-1.6 AYes. This does not affect
substantial equivalence
according to performance
testing.
15Frequency50-60 Hz50-60 Hz50-60 HzNone
Material
IDComparison
ItemProposed Device
Implanter incl.
AccessoriesPredicate Device
Implantmed SI-1015
incl. AccessoriesReference Device
ImplantMED SI-915 (115V
Version) ImplantMED SI-
923 (230V Version) Incl.
AccessoriesDifference Between the
Proposed Device and the
Predicate Device
16Control unit
housingPlastic materialPlastic materialPlastic materialNone
17Tubing outer
shealthCustomer specificCustomer specificCustomer specificNone
Product: Implanter Version:A/C
18Motor with
cableStainless Steel,
Aluminum Alloy (Motor)
and Silicone, Silicone
dioxide,
Polydimethylsiloxane
(Cable)Stainless steelStainless steelYes. This does not raise any
additional questions regarding
substantial equivalence
according to testing
conducted per ISO 10993.
19Surgical
handpiecesChromium plated steel
and chromium coated
brassChromium coated steel
and chromium coated
brassChromium coated steel
and chromium coated
brassYes. This does not raise any
additional questions
regarding substantial
equivalence according to
testing conducted per ISO
  1.                                                                                                                                                                 |  |
    

| 20 | Module | / | Stainless steel | Stainless steel | Yes. The proposed device
does not include a module.
Therefore, material
composition is not applicable. | |
| Hygiene/Maintenance
Surgical Handpieces WP-1L/WP-1, Motors SPM58L, and others | | | | | | |
| Product: Implanter Version:A/0 | | | | | | |
| ID | Comparison
Item | Proposed Device
Implanter incl.
Accessories | Predicate Device
Implantmed SI-1015
incl. Accessories | Reference Device
ImplantMED SI-915 (115V
Version) ImplantMED SI-
923 (230V Version) Incl.
Accessories | Difference Between the
Proposed Device and the
Predicate Device | |
| 21 | Lubrication | After max. 30 minutes of
use
SPM58L:
No lubrication is needed | After max. 30 minutes of
use
EM-19 LC/EM-19:
No lubrication is needed | After max. 30 minutes of
use
Motor with cable:
No lubrication is needed | None | |
| 22 | Cleaning | Rinse under distilled
water or deionized water
(