(85 days)
Not Found
No
The device description and intended use focus on mechanical dental handpieces and attachments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The devices are used for dental procedures such as removing carious material, cavity preparation, root canal preparations, and polishing teeth, which are therapeutic interventions.
No
The document describes devices used for performing dental procedures such as removing material, preparing cavities, and polishing teeth, which are therapeutic or procedural actions, not diagnostic ones.
No
The device description clearly outlines physical, air-powered dental handpieces and attachments, which are hardware components, not software.
Based on the provided text, none of the described devices are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device descriptions clearly state that these devices are used directly on the patient's teeth and mouth for procedures like removing material, preparing cavities, and polishing. They are not used to analyze samples taken from the body.
- The procedures described are clinical dental procedures. They involve direct intervention and manipulation of the patient's oral structures.
The devices described are dental handpieces and attachments used for mechanical procedures within the mouth.
N/A
Intended Use / Indications for Use
ND LOWSPEED AIRMOTOR HANDPIECE (SEVERAL MODELS): 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 LOWSPEED AIRMOTOR (SEVERAL MODELS): 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 (SEVERAL MODELS): 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 (SEVERAL MIDELS): 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 (SEVERAL MODELS): 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 (SEVERAL MODELS): 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.
Product codes (comma separated list FDA assigned to the subject device)
EFB, EGS
Device Description
ND LOWSPEED AIRMOTOR HANDPIECE (SEVERAL MODELS): 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 LOWSPEED AIRMOTOR (SEVERAL MODELS): 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 (SEVERAL MODELS): 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 (SEVERAL MIDELS): 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 (SEVERAL MODELS): 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 (SEVERAL MODELS): 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental clinician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K070869, K896878, K863677, K792445, K962540, K790722
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
- 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
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
Page 1 of _