ND air powered low speed airmotor is used to power various U-type attachment which helps dental clinician perform the hygiene dentistry work. All the devices are autoclavable.
ND air powered low speed airmotor is used to power various attachment which helps dental clinician perform various dental procedures. All the devices are autoclavable.
ND highspeed airturbine handpiece is an air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teeth. All the devices are autoclavable.
ND straight nosecone is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. ES-30A is E-type 1:1 ratio, ESG-30AR is E-type 4:1 ratio, and MWS-30A is Midwest-type 1:1 ratio. All the devices are autoclavable. They accept 2.35mm (3/32") standard burs and can have prophy angles mounted.
ND e-type contra angle is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. EC-20L and EC-30BL are 1:1 ratio, EG-20L is 4:1 ratio, and EGG-20L is 16:1 ratio. All of the devices are autoclavable.
ND u-type prophylaxis angle is used mounted on U-type nose attachment powered by either lowspeed airmotor or electric micromotor for hygiene dentistry work. All the devices are fully autoclavable.

Device Description

ND air powered low speed airmotor is used to power various U-type attachment which helps dental clinician perform the hygiene dentistry work. All the devices are autoclavable.
ND air powered low speed airmotor is used to power various attachment which helps dental clinician perform various dental procedures.
ND highspeed airturbine handpiece is an air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teeth. All the devices are autoclavable.
ND straight nosecone is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. ES-30A is E-type 1:1 ratio, ESG-30AR is E-type 4:1 ratio, and MWS-30A is Midwest-type 1:1 ratio. All the devices are autoclavable. All the devices accepts 2.35mm (3/32") standard burs and can have prophy angles mounted.
ND e-type contra angle is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations and polishing teeth. EC-20L and EC-30BL are 1:1 ratio, EG-20L is 4:1 ratio, and EGG-20L is 16:1 ratio. All of the devices are autoclavable.
ND u-type prophylaxis angle is used mounted on U-type nose attachment powered by either lowspeed airmotor or electric micromotor for hygiene dentistry work. All the devices are fully autoclavable.

AI/ML Overview

The request asks for specific information regarding acceptance criteria and a study proving a device meets these criteria. However, the provided text consists of several 510(k) summaries for various dental handpieces and attachments. These summaries primarily focus on demonstrating "substantial equivalence" to predicate devices rather than presenting detailed acceptance criteria and performance study results.

The concept of "substantial equivalence" in a 510(k) submission means that the new device is as safe and effective as a legally marketed predicate device. The evidence for this is typically based on comparing the new device's technological characteristics, materials, operating principles, and performance specifications to those of the predicate device. It usually does not involve presenting a specific clinical or performance study with acceptance criteria in the manner requested for an AI/clinical device study.

Therefore, most of the requested information cannot be extracted from the provided text because:

Acceptance Criteria and Reported Device Performance (Table): The summaries state that the "performance specification is virtually identical" to the predicate devices. There are no specific quantitative acceptance criteria or detailed performance metrics reported for the subject devices.
Sample size for the test set and data provenance: No new performance studies with test sets are described. The equivalence is based on comparison to existing predicate devices.
Number of experts and their qualifications: Not applicable as no ground truth establishment for a test set is reported.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a comparison of physical device characteristics, not an AI efficacy study.
Standalone (algorithm only) performance: Not applicable, as these are physical medical devices, not algorithms.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How ground truth for the training set was established: Not applicable.

The core argument for acceptance in these documents is based on the similarity of the device's design, materials, and intended use to a previously approved (predicate) device, asserting that this similarity demonstrates equivalent safety and effectiveness.

Here’s a summary of what can be extracted or inferred regarding "acceptance" in the context of these 510(k) submissions:

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate devices. The "reported device performance" is essentially that the device functions identically to the predicate device in its intended use.

Acceptance Criteria (Implicit)	Reported Device Performance
Materials used to manufacture components are similar to predicate device.	Materials are similar to the respective predicate device.
Means of operation is identical to predicate device (e.g., compressed air powers a variable speed rotary vane motor).	Means of operation is identical to the respective predicate device.
Performance specification is virtually identical to predicate device.	Performance specification is virtually identical to the respective predicate device.
Minor differences (e.g., color, size, weight, specific ratios/connection types) do not affect safety or effectiveness.	Differences are minor and do not alter fundamental performance or safety.
Device is autoclavable (where applicable).	All devices are autoclavable (as stated in descriptions).
Accepts standard burs/prophy angles (where applicable).	E-type Straight Nosecone accepts 2.35mm (3/32") standard burs and prophy angles.

2. Study Description and Evidence of Meeting Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria is the 510(k) substantial equivalence comparison against predicate devices. This is not a clinical trial or performance study in the traditional sense, but rather a regulatory submission based on comparative analysis.

Sample size used for the test set and the data provenance: There is no specific "test set" or explicit data provenance mentioned beyond the comparison to the existing predicate devices already on the market. These are retrospective comparisons to existing approved devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the predicate devices' safety and effectiveness was established through their prior market clearance.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
If a standalone performance was done: No standalone algorithm performance was done as this is a physical device submission.
The type of ground truth used: The ground truth for the predicate devices is their previous regulatory clearance based on their demonstrated safety and effectiveness in the market. For the subject devices, the "truth" is the argument of their equivalence to these predicate devices.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In conclusion, the provided documents are 510(k) summaries, which aim to demonstrate substantial equivalence to previously approved devices. They do not contain the type of detailed performance study data, acceptance criteria, test set information, or expert adjudication typically found for AI or clinical performance studies. The "proof" lies in the direct comparison of features and intended use to existing, legally marketed devices.

Summary

{0}------------------------------------------------

MAR 2 0 2008

The Date Prepared : December 14th, 2007

The Company : NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. 59-2 Minami-cho, Itabashi-ku, Tokyo 173-0027, Japan Phone : 813-3955-5307 / Fax : 813-3955-5309 E-mail : shinich@mvi.biglobe.ne.jp The Establishment Registration Number : 9614686 Owner / Operator ID Number : 0910791

The Contact : Charlie Ito / CEO HEAD DENTAL CORPORATION 17972 Sky Park Circle, Suite J, Irvine, CA 92614-6409 Phone : 949-474-0176 / Fax : 949-474-1736 E-mail : HEADDental@aol.com The Establishment Registration Number : 2080470

The Device Trade Name :

ND LOWSPEED AIRMOTOR HANDPIECE (SEVERAL MODELS) Model Number : MD-50M / MD-50B / MD-20M / MD-20B / MP-40M

The Product Code : EFB

Any FDA Document numbers associated with prior formal correspondence with FDA : B000016

The Common or Usual Name : Air-Powered Low Speed Handpiece

The Predicate Device :

510(k) Number : K070869

Trade or Propriety or Model Name : PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422

Manufacturer : DENTALEZ, INC.

Description / Intended Use :

ND air powered low speed airmotor is used to power various U-type attachment which helps dental clinician perform the hygiene dentistry work. All the devices are autoclavable.

Substantial Equivalence :

ND LOWSPEED AIRMOTOR HANDPIECE as submitted is substantially equivalent to PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422, currently being marketed by DENTALEZ INC. Materials used to manufacture the components are similar. Means of operation is identical ; compressed air powers a variable speed rotary vane motor to provide power for various dental procedures. The performance specification is virtually identical. The slight difference between the predicate device and the submitted device is color, size and weight.

{1}------------------------------------------------

510(k) SUMMARY December 14th, 2007 The Date Prepared : The Company : NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. 59-2 Minami-cho, Itabashi-ku, Tokyo 173-0027, Japan Phone : 813-3955-5307 / Fax : 813-3955-5309 E-mail : shinich@mvj.biglobe.ne.jp The Establishment Registration Number : 9614686 Owner / Operator ID Number : 0910791 The Contact : Charlie Ito / CEO HEAD DENTAL CORPORATION 17972 Sky Park Circle, Suite J, Irvine, CA 92614-6409 Phone : 949-474-0176 / Fax : 949-474-1736 E-mail : HEADDental@aol.com The Establishment Registration Number : 2080470 The Device Trade Name : ND LOWSPEED AIRMOTOR ( SEVERAL MODELS) Model Number : ME-20M / ME-20B / ME-80M / ME-80B The Product Code : EFB Any FDA Document numbers associated with prior formal correspondence with FDA : B000016 The Common or Usual Name : Air-Powered Low Speed Motor The Predicate Device : 510(k) Number : K896878 Trade or Propriety or Model Name : Dual Low Speed Motor HANDPIECE SYSTEM WITH MOTOR Manufacturer : MICRO MOTORS, INC. Description / Intended Use : ND air powered low speed airmotor is used to power various attachment which helps dental clinician perform various dental procedures.

Substantial Equivalence :

ND LOWSPEED AIRMOTOR as submitted is substantially equivalent to HANDPIECE SYSTEM WITH MOTOR (SEVERAL MODELS), currently being marketed by Micro Motors Inc. Materials used to manufacture the components are similar. Means of operation is identical ; compressed air powers a variable speed rotary vane motor to provide power for various dental procedures. The performance specification is virtually identical. The slight difference between the predicate device and the submitted device is color, size and weight.

{2}------------------------------------------------

$\qquad K L^{\prime} 3652 .$

510(k) SUMMARY 5.

December 14th, 2007 The Date Prepared : The Company : NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. 59-2 Minami-cho, Itabashi-ku, Tokyo 173-0027, Japan Phone : 813-3955-5307 / Fax : 813-3955-5309 E-mail : shinich@mvj.biglobe.ne.jp The Establishment Registration Number : 9614686 Owner / Operator ID Number : 0910791 Charlie Ito / CEO The Contact : HEAD DENTAL CORPORATION

17972 Sky Park Circle, Suite J, Irvine, CA 92614-6409 Phone : 949-474-0176 / Fax : 949-474-1736 E-mail : HEADDental@aol.com The Establishment Registration Number : 2080470

The Device Trade Name :

ND HIGHSPEED AIRTURBINE HANDPIECE (SEVERAL MODELS) Model Number : TCP-450M / TCP-450B / TCP-350M / TCP-350B / TC-40PM / TC-40PB / TC-35YM / TC-35YB

The Product Code : EFB

Any FDA Document numbers associated with prior formal correspondence with FDA : B000016

The Common or Usual Name : Air-Powered High Speed Handpiece

The Predicate Devices :

510(k) Number : K863677

Trade or Propriety or Model Name : TRADITION HIGHSPEED HANDPIECE Manufacturer : MIDWEST

Description / Intended Use :

ND highspeed airturbine handpiece is an air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teeth. All the devices are autoclavable.

{3}------------------------------------------------

Substantial Equivalence :

ND HIGHSPEED AIRTURBINE HANDPIECE as submitted is substantially equivalent to TRADITION HIGHSPEED HANDPIECE , currently being marketed by MIDWEST. Materials used to manufacture the components are similar. Means of operation is identical ; compressed air powers a variable speed impeller to provide power for various dental procedures. The performance specification is virtually identical. The slight difference between the predicate device and the submitted device is color, size and weight.

{4}------------------------------------------------

K(13652

510(k) SUMMARY 5.

The Date Prepared :	December 14th, 2007
The Company :	NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.
	59-2 Minami-cho, Itabashi-ku, Tokyo 173-0027, Japan
	Phone : 813-3955-5307 / Fax : 813-3955-5309
	E-mail : shinich@mvj.biglobe.ne.jp
	The Establishment Registration Number : 9614686
	Owner / Operator ID Number : 0910791
The Contact :	Charlie Ito / CEO
	HEAD DENTAL CORPORATION
	17972 Sky Park Circle, Suite J, Irvine, CA 92614-6409
	Phone : 949-474-0176 / Fax : 949-474-1736
	E-mail : HEADDental@aol.com
	The Establishment Registration Number : 2080470
The Device Trade Name :	ND STRAIGHT NOSECONE (SEVERAL MIDELS)
	Model Number : ES-30A / ESG-30AR / MWS-30A
The Product Code :	EGS
	Any FDA Document numbers associated with prior formal correspondence with FDA :
	B000017
	The Common or Usual Name : Straight Angle Dental Handpiece Attachment
The Predicate Device :
510(k) Number :	K792445
	Trade or Propriety or Model Name : MW STRAIGHT ATTACHMENT
Manufacturer :	MIDWEST
Description / Intended Use :
	ND straight nosecone is powered by either lowspeed airmotor or electric micromotor for
	removing carious material and excess filling material, cavity and crown preparation, root
	canal preparations, finishing tooth preparations, restorations and polishing teeth. ES-30A is
	E-type 1:1 ratio, ESG-30AR is E-type 4:1 ratio, and MWS-30A is Midwest-type 1:1 ratio.
	All the devices are autoclavable. All the devices accepts 2.35mm (3/32") standard burs and
	can have prophy angles mounted.

{5}------------------------------------------------

Substantial Equivalence :

ND STRAIGHT NOSECONE as submitted is substantially equivalent to MW STRAIGHT ATTACHMENT, currently being marketed by NIDWEST. Materials used to manufacture the components are similar. Means of operation is identical ; powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The performance specification is virtually identical. The difference between the predicate device and the submitted device is ratio (ESG-30AR 4:1) and connection-type (ES-30A and ESG-30AR are E-type).

{6}------------------------------------------------

K073652

510(k) SUMMARY

The Date Prepared :	December 14th, 2007
The Company :	NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.
	59-2 Minami-cho, Itabashi-ku, Tokyo 173-0027, Japan
	Phone : 813-3955-5307 / Fax : 813-3955-5309
	E-mail : shinich@mvj.biglobe.ne.jp
	The Establishment Registration Number : 9614686
	Owner / Operator ID Number : 0910791
The Contact :	Charlie Ito / CEO
	HEAD DENTAL CORPORATION
	17972 Sky Park Circle, Suite J, Irvine, CA 92614-6409
	Phone : 949-474-0176 / Fax : 949-474-1736
	E-mail : HEADDental@aol.com
	The Establishment Registration Number : 2080470
The Device Trade Name :	ND E-TYPE CONTRA ANGLE (SEVERAL MODELS)
	Model Number : FC-20L / FC-30BL / EG-20L / EGG-20L

The Product Code : EGS

Any FDA Document numbers associated with prior formal correspondence with FDA : B000017

The Common or Usual Name : E-type Contra Angle Dental Handpiece Attachment The Predicate Device :

510(k) Number : K962540

Trade or Propriety or Model Name : E-TYPE CONTRA ANGLE NAC-E

Manufacturer : NSK NAKANISHI, INC.

Description / Intended Use :

ND e-type contra angle is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations and polishing teeth. EC-20L and EC-30BL are 1:1 ratio, EG-20L is 4:1 ratio, and EGG-20L is 16:1 ratio. All of the devices are autoclavable.

{7}------------------------------------------------

Substantial Equivalence :

ND E-TYPE CONTRA ANGLE as submitted is substantially equivalent to E-TYPE CONTRA ANGLE NAC-E, currently being marketed by NSK NAKANISHI, INC. Materials used to manufacture the components are similar. Means of operation is identical ; powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The performance specification is virtually identical. The slight difference between the predicate device and the submitted device is color, size and weight. The 4:1 and the 16:1 speed ratio are also available, in addition to the 1:1.

{8}------------------------------------------------

The Date Prepared : December 14th, 2007 The Company : NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. 59-2 Minami-cho, Itabashi-ku, Tokyo 173-0027, Japan Phone : 813-3955-5307 / Fax : 813-3955-5309 E-mail : shinich@mvi.biglobe.ne.jp The Establishment Registration Number : 9614686 Owner / Operator ID Number : 0910791 The Contact : Charlie Ito / CEO HEAD DENTAL CORPORATION 17972 Sky Park Circle, Suite J, Irvine, CA 92614-6409 Phone : 949-474-0176 / Fax : 949-474-1736 E-mail : HEADDental@aol.com The Establishment Registration Number : 2080470 The Device Trade Name : ND U-TYPE PROPHYLAXIS ANGLE (SEVERAL MODELS) RA-10PS / RA-10PK / RA-50PS / RA-50PK / RA-10PS / RA-10PK / RA-50PS / RA-50PK / DC-10L / DU-20L / DU-20L The Product Code : EGS

Any FDA Document numbers associated with prior formal correspondence with FDA : B000017

The Common or Usual Name : U-type Contra Angle Dental Handpiece Attachment

The Predicate Device :

510(k) Number : K790722

Trade or Propriety or Model Name : PROHYLAXIS ANGLE

Manufacturer : YOUNG DENTAL MANUFACTURING CO, LLC.

Description / Intended Use :

ND u-type prophylaxis angle is used mounted on U-type nose attachment powered by either lowspeed airmotor or electric micromotor for hygiene dentistry work. All the devices are fully autoclavable.

Substantial Equivalence :

ND U-TYPE PROPHYLAXIS ANGLE as submitted is substantially equivalent to PROPHYLAXIS ANGLE, currently being marketed by YOUNG DENTAL MANUFACTURING CO. Materials used to manufacture the components are similar. Means of operation is identical ; it is used mounted on U-type nose attachment powered by either lowspeed airmotor or electric micromotor for hygiene dentistry work. All the models are fully autuclavable. The slight difference between the predicate device and the submitted device is color, size and weight.

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing the agency's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nakamura Dental Manufacturing Company, Limited C/O Mr. Charlie Ito Chief Executive Officer Head Dental Corporation 17972 Sky Park Circle, Suite J Irvine, California 92614-6409

MAR 2 0 2008

Re: K073652

Trade/Device Name: ND Low Speed Airmotor (Several Models)

Model Number: MD-50M / MD-50B / MD-20M / MD-20B / MP-40M / ME-20M / ME-20B / ME-80M / ME-80B

ND U-Type Prophylaxis Angle (Several Models) Model Number: RA-10PS/ RA-10PK / RA-50PS / RA-50PK / RA-10PS / RA-10PK / RA-50PS / RA-50PK / DC-10L / DU-20L / DU-20L

ND E-Type Contra Angle (Several Models) Model Number: EC-20L / EC-30BL / EG-20L / EG-20L / EGG-20L

ND E-Type Straight Nosecone (Several Models) Model Number: ES-30A / ESG-30AR / MWS-30A

ND Highspeed Airturbine Handpiece (Several Models) Model Number: TCP-450M / TCP-450B / TCP-350M / TCP-350B / TC-40PM / TC-40PB / TC-35YM / TC-35YB

Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB, EGS Dated: December 14, 2007 Received: December 26, 2007

Dear Mr. Ito:

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

{10}------------------------------------------------

Page 2 - Mr. Ito

approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Supe fuare
Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

{11}------------------------------------------------

510(k) Number (if known) : K 073652

ND LOW SPEED AIRMOTOR (SEVERAL MODELS) Device Name : Model Number : ME-20M / ME-20B / ME-80M / ME-80B

Product Code : EFB

Any FDA Document numbers associated with prior formal correspondence with FDA : B000016 Indications for Use :

ND air powered low speed airmotor is used to power various attachment which helps dental clinician perform various dental procedures. All the devices are autoclavable.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------	--

SWORN TO AND SUBSCRIBED BEFORE ME

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

{12}------------------------------------------------

510(k) Number (if known) : K 0 736 52

ND LOWSPEED AIRMOTOR HANDPIECE (SEVERAL MODELS) Device Name : Model Number : MD-50M / MD-50B / MD-20M / MD-20B / MP-40M

Product Code : EFB

Any FDA Document numbers associated with prior formal correspondence with FDA : B000016 Indications for Use :

ND air powered low speed airmotor is used to power various U-type attachment which helps dental clinician perform the hygiene dentistry work. All the devices are autoclavable.

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Paone

(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K073652

Page 1 of __

{13}------------------------------------------------

K673652 510(k) Number (if known) :

ND HIGHSPEED AIRTURBINE HANDPIECE (SEVERAL MODELS) Device Name : Model Number : TCP-450M / TCP-450B / TCP-350M / TCP-350B / TC-40PM / TC-40PB / TC-35YM / TC-35YB

Product Code : EFB

Any FDA Document numbers associated with prior formal correspondence with FDA : B000016 Indications for Use :

ND highspeed airturbine handpiece is an air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teeth. All the devices are autoclavable.

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sudon Kumre

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K073652

{14}------------------------------------------------

Kb73652 510(k) Number (if known) :

ND E-TYPE STRAIGHT NOSECONE (SEVERAL MIDELS) Device Name : Model Number : ES-30A / ESG-30AR / MWS-30A

Product Code : EGS

Any FDA Document numbers associated with prior formal correspondence with FDA : B000017 Indications for Use :

ND straight nosecone is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. ES-30A is E-type 1:1 ratio, ESG-30AR is E-type 4:1 ratio, and MWS-30A is Midwest-type 1:1 ratio. All the devices are autoclavable. They accept 2.35mm (3/32") standard burs and can have prophy angles mounted.

AND/OR Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Qffice of Device Evaluation (ODE)

Susa Runse
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K673657

{15}------------------------------------------------

510(k) Number (if known) :

ND E-TYPE CONTRA ANGLE (SEVERAL MODELS) Device Name : Model Number : EC-20L / EC-30BL / EG-20L / EGG-20L

Product Code : EGS

Any FDA Document numbers associated with prior formal correspondence with FDA : B000017 Indications for Use :

ND e-type contra angle is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. EC-20L and EC-30BL are 1:1 ratio, EG-20L is 4:1 ratio, and EGG-20L is 16:1 ratio. All of the devices are autoclavable.

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sween Kumar

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: KC73632

{16}------------------------------------------------

510(k) Number (if known): 长67365Z

Device Name : ND U-TYPE PROPHYLAXIS ANGLE (SEVERAL MODELS) Model Number : RA-10PS / RA-10PK / RA-50PS / RA-50PK / RA-10PS / RA-10PK / RA-50PS / RA-50PK / DC-10L / DU-20L / DU-20L

Product Code : EGS

Any FDA Document numbers associated with prior formal correspondence with FDA : B000017 Indications for Use :

ND u-type prophylaxis angle is used mounted on U-type nose attachment powered by either lowspeed airmotor or electric micromotor for hygiene dentistry work. All the devices are fully autoclavable.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suon Kunes

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K084652

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Regulation Number and Section

§ 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.