(175 days)
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.
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.
This document is a 510(k) Premarket Notification for Henry Schein/Handpiece Headquarters U-Type Contra Angles and U-Type Sectional Contra Angles. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or target performance format. Instead, the demonstration of equivalence is based on a direct comparison of technological characteristics and performance (specifically heat generation and speed capabilities) between the new device and the predicate device. The "conclusion" section states that the non-clinical tests did not raise any safety or efficacy concerns and that the device is substantially equivalent based on these comparisons.
The following table summarizes the comparative performance presented in Attachment 8 (H1-Summary table of comparing the technological characteristics between the subjects to predicate devices):
| Metric/Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Henry Schein/Handpiece Headquarters U-TYPE contra angles) | Conclusion |
|---|---|---|---|
| Indications for Use | ND U-type prophylaxis angles: used to mount on U-type nose attachment, powered by low speed air motor or electric micro motor for hygiene dentistry work. Autoclavable. | U-Type Contra Angles and U-Type Sectional contra angles: used to mount on U-Type Nose Attachments, powered by low speed air motors or electric micro motors. Intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. | Similar (The new device explicitly lists broader applications beyond "hygiene dentistry work," but the overall function of mounting to a U-type nose attachment and being powered by low-speed motors for dental procedures remains the same. The document implies no new safety/effectiveness concerns despite the broader listed uses.) |
| Technical Characteristic | |||
| Body length (U-Type Contra Angle 40,000 rpm & 20,000 rpm) | 3.117" (Model DC-10L) | 3.114" | Similar |
| Weight (U-Type Contra Angle 40,000 rpm & 20,000 rpm) | 29.9g (Model DC-10L) | 29.4g | Similar |
| Bearing type (U-Type Contra Angle 40,000 rpm & 20,000 rpm) | Phosphor Bronze bushing bearings (Model DC-10L) | Precision ball bearings | Performance Better (Precision ball bearings can perform better and have less friction (less heat generating) compared to Phosphor Bronze bushing bearings.) |
| Speed range (U-Type Contra Angle 40,000 rpm & 20,000 rpm) | 0-15,000 rpm (Model DC-10L) | 0-40,000 rpm | Higher Speed Capability (Precision ball bearing can handle higher speed.) |
| Heat generate after 5 mins free run (U-Type Contra Angle 40,000 rpm & 20,000 rpm) | From 21 °C to 29.5°C (Model DC-10L) | From 21 °C to 26°C | Similar |
| Body length (U-Type Contra Angle Sectional 40,000 rpm & 20,000 rpm) | 3.110" (Model DC-20L) | 3.100" | Similar |
| Weight (U-Type Contra Angle Sectional 40,000 rpm & 20,000 rpm) | 35.0g (Model DC-20L) | 32.9g | Similar |
| Bearing type (U-Type Contra Angle Sectional 40,000 rpm & 20,000 rpm) | Phosphor Bronze bushing bearings (Model DC-20L) | Precision ball bearings | Performance Better (Precision ball bearings can perform better and have less friction (less heat generating) compared to Phosphor Bronze bushing bearings.) |
| Speed range (U-Type Contra Angle Sectional 40,000 rpm & 20,000 rpm) | 0-20,000 rpm (Model DC-20L) | 0-40,000 rpm | Higher Speed Capability (Precision ball bearing can handle higher speed.) |
| Heat generate after 5 mins free run (U-Type Contra Angle Sectional 40,000 rpm & 20,000 rpm) | From 21 °C to 29°C (Model DC-20L) | From 21 °C to 27°C | Similar |
| Body length (U-Type Contra Angle Friction Grip 20,000 rpm) | 3.14" (Model DC-10FG) | 3.14" | Identical |
| Weight (U-Type Contra Angle Friction Grip 20,000 rpm) | 30.4g (Model DC-10FG) | 31.16g | Similar |
| Bearing type (U-Type Contra Angle Friction Grip 20,000 rpm) | Phosphor Bronze bushing bearings (Model DC-10FG) | Precision ball bearings | Performance Better (Precision ball bearings can perform better and have less friction (less heat generating) compared to Phosphor Bronze bushing bearings.) |
| Speed range (U-Type Contra Angle Friction Grip 20,000 rpm) | 0-15,000 rpm (Model DC-10FG) | 0-20,000 rpm | Higher Speed Capability (Precision ball bearing can handle higher speed.) |
| Heat generate after 5 mins free run (U-Type Contra Angle Friction Grip 20,000 rpm) | From 21 °C to 29.7°C (Model DC-10FG) | From 21 °C to 29.7°C | Identical |
| Body length (U-Type Sectional Contra Angle Friction Grip 20,000 rpm) | 3.15" (Model DC-20FG) | 3.14" | Similar |
| Weight (U-Type Sectional Contra Angle Friction Grip 20,000 rpm) | 31.2g (Model DC-20FG) | 32.7g | Similar |
| Bearing type (U-Type Sectional Contra Angle Friction Grip 20,000 rpm) | Phosphor Bronze bushing bearings (Model DC-20FG) | Precision ball bearings | Performance Better (Precision ball bearings can perform better and have less friction (less heat generating) compared to Phosphor Bronze bushing bearings.) |
| Speed range (U-Type Sectional Contra Angle Friction Grip 20,000 rpm) | 0-15,000 rpm (Model DC-20FG) | 0-20,000 rpm | Higher Speed Capability (Precision ball bearing can handle higher speed.) |
| Heat generate after 5 mins free run (U-Type Sectional Contra Angle Friction Grip 20,000 rpm) | From 21 °C to 28.1°C (Model DC-20FG) | From 21 °C to 28.1°C | Identical |
| Other characteristics (Speed ratio, Attachments, Chuck type, Mount, Patient contact surfaces) | All identical to predicate devices. | All identical to predicate devices. | Identical |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the numerical sample size for the test set used in the "in-house" comparison testing. It simply refers to "these U-type contra angles" and "predicate devices."
- Data Provenance: The testing was conducted "in house per ISO 7785-2:1995 (section 7 of this 510(k))." This indicates the data was generated internally by the manufacturer, rather than being from a specific country of origin or being retrospective/prospective clinical data involving patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided in the document. The study is a benchtop comparative performance study of mechanical devices, not a clinical study requiring expert interpretation of medical images or patient outcomes.
4. Adjudication method for the test set:
Not applicable. This was a direct comparative measurement of physical characteristics and performance based on a standard (ISO 7785-2:1995). No adjudication method is described or required for this type of test.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a 510(k) submission for dental handpiece attachments, which are mechanical devices, not AI/software as a medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is about mechanical dental devices, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this engineering comparison study was established by objective physical measurements based on the requirements of ISO 7785-2:1995, which pertains to dental handpieces. The predicate device's characteristics and performance values served as the benchmark for comparison.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI-based device, so there is no training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the central image.
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.
{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 (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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
{2}------------------------------------------------
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)
Page 1 of 1
{3}------------------------------------------------
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 HEADQUARTERS620 S. Placentia Ave., Placentia CA 92870Tel. 714-579-0175 Fax. 714-579-0186 |
|---|---|
| b- Contact person: | Tina Steffanie-Oak, Tel. 717-335-7230, ext. 4150 Fax. 717-335-7240Email: tina.steffanie-oak@henryschein.com |
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.
{4}------------------------------------------------
H1-Summary table of comparing the technological characteristics between the subjects to
predicate devices:
| comparison | Henry Schein/HandpieceHeadquarters U-TYPE contraangle | Predicate: NakamuraDental U-Typecontra angle | Conclusion |
|---|---|---|---|
| U-Type Contra angle 40,000 rpm & U-Type contra angle 20,000 rpm | ModelDC-10L | ||
| Indications of use | The U-Type Contra Angles andU-Type Sectional contra anglesare used to mount on U-TypeNose Attachments and poweredby either low speed air motors orelectric micro motors. TheseU-Types are intended forremoving carious material, cavityand crown preparations,finishing tooth preparations,reducing hard tooth structures,restorations and polishing teeth. | ND u-type prophylaxisangle is use tomounted on U-typenose attachmentpowered by either lowspeed air motor orelectric micro motorfor hygiene dentistrywork. All devices arefully Autoclavable. | Similar |
| Technical characteristic | |||
| Body length | 3.114" | 3.117" | Similar |
| Weight | 29.4g | 29.9g | Similar |
| Bearing type | Precision ball bearings | Phosphor Bronzebushing bearings | Precision Ball bearingscan performance betterand less friction (lessheat generating)compare to PhosphorBronze bushingbearings |
| Speed range | 0-40,000 rpm | 0-15,000 rpm | Precision ball bearingcan handle higherspeed |
| Speed ratio | 1:1 | 1:1 | Identical |
| Attachments | Low speed motor | Low speed motor | Identical |
| Chuck typeMount | LatchU-Type | LatchU-type | Identical |
| Patient contactsurfaces | Brass with Nickel ChromePlating | Brass and NickelChrome Plating | Identical |
| Heat generateafter 5 minutesfree 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 Sectional40,000 rpm & U-Type contraangle 20,000 rpm | ModelDC-20L | ||
| Indications of use | The U-Type Contra Angles andU-Type Sectional contra anglesare used to mount on U-TypeNose Attachments and powered | ND u-type prophylaxisangle is use tomounted on U-typenose attachment | Similar |
| by either low speed air motors orelectric micro motors. TheseU-Types are intended forremoving carious material, cavityand crown preparations,finishing tooth preparations,reducing hard tooth structures,restorations and polishing teeth. | powered by either lowspeed air motor orelectric micro motorfor hygiene dentistrywork. All devices arefully Autoclavable. | ||
| Technical characteristic | |||
| Body length | 3.100" | 3.110" | similar |
| Weight | 32.9g | 35.0g | similar |
| Bearing type | Precision ball bearings | Phosphor Bronzebushing bearings | Precision Ball bearingscan performance betterand less friction (lessheat generating)compare to PhosphorBronze bushingbearings |
| Speedrange | 0-40,000 rpm | 0-20,000 rpm | Precision ball bearingcan handle higherspeed |
| 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 contactsurfaces | Brass with Nickel ChromePlating | Brass and NickelChrome Plating | identical |
| Heat generateafter 5 minutesfree run | From 21 °C to 27°C | From 21 °C to 29°C | Similar |
| U-Type Contra angle FrictionGrip 20,000 rpm | ModelDC-10FG | ||
| Indications of use | The U-Type Contra Angles andU-Type Sectional contra anglesare used to mount on U-TypeNose Attachments and poweredby either low speed air motors orelectric micro motors. TheseU-Types are intended forremoving carious material, cavityand crown preparations,finishing tooth preparations,reducing hard tooth structures,restorations and polishing teeth. | ND u-type prophylaxisangle is use tomounted on U-typenose attachmentpowered by either lowspeed air motor orelectric micro motorfor hygiene dentistrywork. All devices arefully Autoclavable. | Similar |
| Technical characteristics | |||
| Body length | 3.14" | 3.14" | Identical |
| Weight | 31.16g | 30.4g | similar |
| Bearing type | Precision ball bearings | Phosphor Bronzebushing bearings | Precision Ball bearingscan performance betterand less friction (less) |
| heat generating)compare to PhosphorBronze bushingbearings | |||
| Speed range | 0-20,000 rpm | 0-15,000 rpm | Precision ball bearingcan handle higherspeed |
| 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 contactsurfaces | Brass with Nickel ChromePlating | Brass and NickelChrome Plating | identical |
| Heat generateafter 5 minutesfree run | From 21 °C to 29.7°C | From 21 °C to 29.7°C | Identical |
| U-Type Sectional Contra angleFriction Grip 20,000 rpm | ModelDC-20FG | ||
| Indications of use | The U-Type Contra Angles andThe U-Type Sectional contra anglesare used to mount on U-TypeNose Attachments and poweredby either low speed air motors orelectric micro motors. TheseU-Types are intended forremoving carious material, cavityand crown preparations,finishing tooth preparations,reducing hard tooth structures,restorations and polishing teeth. | ND u-type prophylaxisangle is use tomounted on U-typenose attachmentpowered by either lowspeed air motor orelectric micro motorfor hygiene dentistrywork. All devices arefully Autoclavable. | Similar |
| Technical characteristic | |||
| Body length | 3.14" | 3.15" | Similar |
| Weight | 32.7g | 31.2g | similar |
| Bearing type | Precision ball bearings | Phosphor Bronzebushing bearings | Precision Ball bearings canperformance better andless friction (less heatgenerating) compare toPhosphor Bronze bushingbearings |
| Speed range | 0-20,000 rpm | 0-15,000 rpm | Precision ball bearing canhandle 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 contactsurfaces | Brass with Nickel ChromePlating | Brass and NickelChrome Plating | identical |
| Heat generateafter 5 minutesfree run | From 21 °C to 28.1°C | From 21 °C to28.1°C | Identical |
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
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.
§ 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.