U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE

K141125 · Handpiece Headquarters · EGS · Oct 23, 2014 · Dental

Device Facts

• Record ID: K141125
• Device Name: U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE
• Applicant: Handpiece Headquarters
• Product Code: EGS · Dental
• Decision Date: Oct 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The U-Type Contra Angles and U-Type Sectional Contra Angles are used to mount on U-Type Nose Attachments and powered by either low speed air motors or electric micro motors. These U-Type are intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

Device Story

Dental handpiece attachments; mount onto U-Type nose attachments; powered by low-speed air or electric micro-motors. Device transmits rotational speed and torque from motor to dental bur or tool. Used by dentists/hygienists in clinical settings for restorative and hygiene procedures. Precision ball bearings reduce friction and heat compared to traditional bushing bearings, allowing higher rotational speeds. Output is mechanical rotation for tooth preparation and polishing. Benefits include efficient material removal and tooth finishing.

Clinical Evidence

No clinical data. Bench testing only. Comparative performance testing conducted per ISO 7785-2:1995, including speed range, heat generation, and physical dimensions, demonstrated substantial equivalence to predicate.

Technological Characteristics

Materials: Brass with Nickel Chrome plating. Bearing type: Precision ball bearings. Speed ratio: 1:1. Chuck type: Latch or Friction Grip. Mount: U-Type. Connectivity: Mechanical attachment to low-speed air/electric motors. Sterilization: Autoclavable.

Indications for Use

Indicated for dental professionals performing procedures including removal of carious material, cavity and crown preparations, finishing tooth preparations, reduction of hard tooth structures, restorations, and tooth polishing.

Regulatory Classification

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.

Predicate Devices

• ND U-TYPE PROPHYLAXIS ANGLES (K073652)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 23, 2014

Handpiece Headquarters Tina Steffanie-Oak Senior Regulatory Specialist 620 S. Placentia Avenue Placentia, California 92870

Re: K141125

Trade/Device Name: Henry Schein/Handpiece Headquarters U-type Contra Angles and U-type Sectional Contra Angle Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: September 23, 2014 Received: September 25, 2014

Dear Ms. Steffanie-Oak:

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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): K141125

Device Name: Henry Schein/Handpiece Headquarters U-Type Contra Angles and U-Type Sectional Contra Angles

Indications for Use:

The U-Type Contra Angles and U-Type Sectional Contra Angles are used to mount on U-Type Nose Attachments and powered by either low speed air motors or electric micro motors. These U-Type are intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

Prescription Use AND/OR (Per 21 CFR 801 Subpart D) Subpart C)

Over-The-Counter Use

(Per 21 CFR 801

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# ATTACHMENT 8 SMDA 510(K) SUMMARY

Image /page/3/Picture/1 description: The image shows the logo for "Handpiece Headquarters", which is "A Henry Schein Company". The words "Handpiece Headquarters" are in a large, bold, red font. Above the words is a black line that looks like a heart rate monitor.

#### 510(K) SUMMARY: Henry Schein / Handpiece Headquarters: U-Type Contra Angles & U-Type Sectional Contra Angles.

| a- Submitted by: | HANDPIECE HEADQUARTERS<br>620 S. Placentia Ave., Placentia CA 92870<br>Tel. [phone] Fax. [phone] |
|--------------------|-----------------------------------------------------------------------------------------------------------------|
| b- Contact person: | Tina Steffanie-Oak, Tel. [phone], ext. 4150 Fax. [phone]<br>Email: [e-mail] |

c- Date summary prepared: 09/22/14

#### d- Device Name:

Trade or Proprietary Name: Henry Schein / Handpiece Headquarters:

- 1-U-Type Contra Angle 20,000 rpm
- 2-U-Type Contra Angle 40,000 rpm
- 3-U-Type Contra Angle Friction Grip
- 4-U-Type Sectional Contra Angle 20,000 rpm
- 5-U-Type Sectional Contra Angle 40,000 rpm
- 6-U-Type Sectional Contra Angle Friction Grip

Common Name: U-Type Contra Angle Handpiece Attachments.

Classification Name:

Class I Device, 21CFR 872.4200, Dental Handpiece and Accessories. EGS

#### e- Substantial Equivalency is claimed against the following devices:

ND U-TYPE PROPHYLAXIS ANGLES (SEVERAL MODELS)

NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. - K073652

#### f- Description of the device:

U-Type contra angles and U-Type sectional contra angles are used to mount on U-Type Nose Attachments and powered by either low speed air motors or low speed electric motors. These U-Type Contra Angle Attachments are gear 1:1 to the low speed air motors or low speed electrical motors. As results, they transmit the same speed and torque from the connected air motors or electric motors.

#### g- Statement of Intended Use:

The U-Type Contra Angles and U-Type Sectional contra angles are used to mount on U-Type Nose Attachments and powered by either low speed air motors or electric micro motors. These U-Types are intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

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H1-Summary table of comparing the technological characteristics between the subjects to
predicate devices:

| comparison | Henry Schein/Handpiece<br>Headquarters U-TYPE contra<br>angle | Predicate: Nakamura<br>Dental U-Type<br>contra angle | Conclusion |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | U-Type Contra angle 40,000 rpm & U-Type contra angle 20,000 rpm | Model<br>DC-10L | |
| Indications of use | The U-Type Contra Angles and<br>U-Type Sectional contra angles<br>are used to mount on U-Type<br>Nose Attachments and powered<br>by either low speed air motors or<br>electric micro motors. These<br>U-Types are intended for<br>removing carious material, cavity<br>and crown preparations,<br>finishing tooth preparations,<br>reducing hard tooth structures,<br>restorations and polishing teeth. | ND u-type prophylaxis<br>angle is use to<br>mounted on U-type<br>nose attachment<br>powered by either low<br>speed air motor or<br>electric micro motor<br>for hygiene dentistry<br>work. All devices are<br>fully Autoclavable. | Similar |
| Technical characteristic | | | |
| Body length | 3.114" | 3.117" | Similar |
| Weight | 29.4g | 29.9g | Similar |
| Bearing type | Precision ball bearings | Phosphor Bronze<br>bushing bearings | Precision Ball bearings<br>can performance better<br>and less friction (less<br>heat generating)<br>compare to Phosphor<br>Bronze bushing<br>bearings |
| Speed range | 0-40,000 rpm | 0-15,000 rpm | Precision ball bearing<br>can handle higher<br>speed |
| Speed ratio | 1:1 | 1:1 | Identical |
| Attachments | Low speed motor | Low speed motor | Identical |
| Chuck type<br>Mount | Latch<br>U-Type | Latch<br>U-type | Identical |
| Patient contact<br>surfaces | Brass with Nickel Chrome<br>Plating | Brass and Nickel<br>Chrome Plating | Identical |
| Heat generate<br>after 5 minutes<br>free run | From 21 °C to 26°C | From 21 °C to 29.5°C | Similar |
| Head type | Contra angle | Contra angle | Identical |
| | U-Type Contra angle Sectional<br>40,000 rpm & U-Type contra<br>angle 20,000 rpm | Model<br>DC-20L | |
| Indications of use | The U-Type Contra Angles and<br>U-Type Sectional contra angles<br>are used to mount on U-Type<br>Nose Attachments and powered | ND u-type prophylaxis<br>angle is use to<br>mounted on U-type<br>nose attachment | Similar |
| by either low speed air motors or<br>electric micro motors. These<br>U-Types are intended for<br>removing carious material, cavity<br>and crown preparations,<br>finishing tooth preparations,<br>reducing hard tooth structures,<br>restorations and polishing teeth. | | | powered by either low<br>speed air motor or<br>electric micro motor<br>for hygiene dentistry<br>work. All devices are<br>fully Autoclavable. |
| Technical characteristic | | | |
| Body length | 3.100" | 3.110" | similar |
| Weight | 32.9g | 35.0g | similar |
| Bearing type | Precision ball bearings | Phosphor Bronze<br>bushing bearings | Precision Ball bearings<br>can performance better<br>and less friction (less<br>heat generating)<br>compare to Phosphor<br>Bronze bushing<br>bearings |
| Speed<br>range | 0-40,000 rpm | 0-20,000 rpm | Precision ball bearing<br>can handle higher<br>speed |
| Speed ratio | 1:1 | 1:1 | Identical |
| Attachments | Low speed motor | Low speed motor | identical |
| Chuck type | Latch | Latch | identical |
| Mount | U-Type | U-type | Identical |
| Patient contact<br>surfaces | Brass with Nickel Chrome<br>Plating | Brass and Nickel<br>Chrome Plating | identical |
| Heat generate<br>after 5 minutes<br>free run | From 21 °C to 27°C | From 21 °C to 29°C | Similar |
| | U-Type Contra angle Friction<br>Grip 20,000 rpm | Model<br>DC-10FG | |
| Indications of use | The U-Type Contra Angles and<br>U-Type Sectional contra angles<br>are used to mount on U-Type<br>Nose Attachments and powered<br>by either low speed air motors or<br>electric micro motors. These<br>U-Types are intended for<br>removing carious material, cavity<br>and crown preparations,<br>finishing tooth preparations,<br>reducing hard tooth structures,<br>restorations and polishing teeth. | ND u-type prophylaxis<br>angle is use to<br>mounted on U-type<br>nose attachment<br>powered by either low<br>speed air motor or<br>electric micro motor<br>for hygiene dentistry<br>work. All devices are<br>fully Autoclavable. | Similar |
| Technical characteristics | | | |
| Body length | 3.14" | 3.14" | Identical |
| Weight | 31.16g | 30.4g | similar |
| Bearing type | Precision ball bearings | Phosphor Bronze<br>bushing bearings | Precision Ball bearings<br>can performance better<br>and less friction (less) |
| | | | |
| | | | heat generating)<br>compare to Phosphor<br>Bronze bushing<br>bearings |
| Speed range | 0-20,000 rpm | 0-15,000 rpm | Precision ball bearing<br>can handle higher<br>speed |
| Speed ratio | 1:1 | 1:1 | Identical |
| Attachments | Low speed motor | Low speed motor | identical |
| Chuck type | Friction Grip | Friction Grip | identical |
| Mount | U-Type | U-type | Identical |
| Patient contact<br>surfaces | Brass with Nickel Chrome<br>Plating | Brass and Nickel<br>Chrome Plating | identical |
| Heat generate<br>after 5 minutes<br>free run | From 21 °C to 29.7°C | From 21 °C to 29.7°C | Identical |
| | | | |
| | U-Type Sectional Contra angle<br>Friction Grip 20,000 rpm | Model<br>DC-20FG | |
| Indications of use | The U-Type Contra Angles and<br>The U-Type Sectional contra angles<br>are used to mount on U-Type<br>Nose Attachments and powered<br>by either low speed air motors or<br>electric micro motors. These<br>U-Types are intended for<br>removing carious material, cavity<br>and crown preparations,<br>finishing tooth preparations,<br>reducing hard tooth structures,<br>restorations and polishing teeth. | ND u-type prophylaxis<br>angle is use to<br>mounted on U-type<br>nose attachment<br>powered by either low<br>speed air motor or<br>electric micro motor<br>for hygiene dentistry<br>work. All devices are<br>fully Autoclavable. | Similar |
| Technical characteristic | | | |
| Body length | 3.14" | 3.15" | Similar |
| Weight | 32.7g | 31.2g | similar |
| Bearing type | Precision ball bearings | Phosphor Bronze<br>bushing bearings | Precision Ball bearings can<br>performance better and<br>less friction (less heat<br>generating) compare to<br>Phosphor Bronze bushing<br>bearings |
| Speed range | 0-20,000 rpm | 0-15,000 rpm | Precision ball bearing can<br>handle higher speed |
| Speed ratio | 1:1 | 1:1 | Identical |
| Attachments | Low speed motor | Low speed motor | identical |
| Chuck type | Friction Grip | Friction Grip | identical |
| Mount | U-Type | U-type | Identical |
| Patient contact<br>surfaces | Brass with Nickel Chrome<br>Plating | Brass and Nickel<br>Chrome Plating | identical |
| Heat generate<br>after 5 minutes<br>free run | From 21 °C to 28.1°C | From 21 °C to<br>28.1°C | Identical |

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#### H2-Summary of comparing technical characteristic:

Base on comparing table above, the principles of operation and design features of the Handpiece Headquarters/Henry Schein U-Type contra angles are identical to Nakamura Dental ND U-type prophylaxis angles. The indications for use of the Handpiece Headquarters/Henry Schein U-Type contra angles are similar to the predicate devices. Heat generating after 5 minutes of free run for these U-type contra angles are similar to predicate devices.

Handpiece Headquarters/Henry Schein U-Type contra angles can achieve a higher speed of rotation compare to Nakamura Dental ND U-type prophylaxis angles because of the improving bearing type that using in these U-type contra angles. Precision ball bearings in high speed handpieces which have proven to improve the life cycles of the handpieces due to minimal friction in operation of these bearings. On the other hand, Phosphor bronze bushing bearings used in Nakamura Dental U-type prophylaxis angles which could not achieve higher speed of rotation due to higher friction generated in these bearings in operation. In order to evaluate differences these devices which do not affectiveness, the comparison testing was conducted testing in house per ISO 7785-2:1995 (section 7 of this 510(k)) which was used for comparison the performance between Handpiece Headquarters/Henry Schein U-type contra angles to predicate devices. Base on the results, the Handpiece Headquarters/Henry Schein U-type contra angles are substantially equivalent to the predicates and do not raise any new safety and effectiveness concern.

#### H-3 summary of Lead testing results:

Negative lead testing results for these U-types

#### H-4 Biocompatibility

Patient-contact portion of these U-type handpieces are made of brass and plated with Nickel Chrome which commonly used for most dental handpieces. They have history of biocompatibility.

#### i- Safety and effectiveness of the device:

U-Type Contra Angles and U-Type Sectional Contra Angles are as safe and effective as the predicate devices as cited above.

### J - Conclusion:

The non-clinical tests did not raise any safety or efficacy concerns. Based on our assessment of the non-clinical tests that were completed, which include comparative testing between the subject and predicate device, review of technological characteristics, performance testing, and material testing, Handpiece Headquarters believes that the U-Type Contra Angles and U-Type Sectional Contra Angles are substantially equivalent to the predicate devices identified.