(175 days)
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No
The document describes a mechanical dental handpiece attachment and does not mention any AI or ML components or functionalities.
No
The device is used for mechanical dental procedures such as removing carious material and polishing teeth, which are not considered therapeutic interventions where a disease or condition is treated.
No
This device is used for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations, and polishing teeth, which are all treatment-oriented procedures rather than diagnostic ones.
No
The device description clearly indicates it is a physical contra angle attachment used with air or electric motors, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed directly on the patient's teeth (removing carious material, cavity and crown preparations, etc.). This is a clinical procedure, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a mechanical device used for dental procedures. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device clearly falls outside of that definition.
N/A
Intended Use / 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) Over-The-Counter Use (Per 21 CFR 801 Subpart C)
Product codes (comma separated list FDA assigned to the subject device)
EGS
Device Description
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 electric motors. As results, they transmit the same speed and torque from the connected air motors or electric motors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison testing was conducted in-house per ISO 7785-2:1995 to compare the performance between Handpiece Headquarters/Henry Schein U-type contra angles and predicate devices. The devices showed similar heat generation after 5 minutes of free run compared to predicate devices. The subject devices can achieve higher speeds due to the use of precision ball bearings, which offer less friction compared to the phosphor bronze bushing bearings used in the predicate devices. The non-clinical tests did not raise any safety or efficacy concerns.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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.
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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
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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
620 S. Placentia Ave., Placentia CA 92870
Tel. 714-579-0175 Fax. 714-579-0186 |
|--------------------|-----------------------------------------------------------------------------------------------------------------|
| b- Contact person: | Tina Steffanie-Oak, Tel. 717-335-7230, ext. 4150 Fax. 717-335-7240
Email: 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.
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H1-Summary table of comparing the technological characteristics between the subjects to
predicate devices:
| comparison | Henry Schein/Handpiece
Headquarters U-TYPE contra
angle | Predicate: Nakamura
Dental U-Type
contra angle | Conclusion |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | U-Type Contra angle 40,000 rpm & U-Type contra angle 20,000 rpm | Model
DC-10L | |
| Indications of 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. | ND u-type prophylaxis
angle is use to
mounted on U-type
nose attachment
powered by either low
speed air motor or
electric micro motor
for hygiene dentistry
work. All devices are
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
bushing bearings | Precision Ball bearings
can performance better
and less friction (less
heat generating)
compare to Phosphor
Bronze bushing
bearings |
| Speed range | 0-40,000 rpm | 0-15,000 rpm | Precision ball bearing
can handle higher
speed |
| Speed ratio | 1:1 | 1:1 | Identical |
| Attachments | Low speed motor | Low speed motor | Identical |
| Chuck type
Mount | Latch
U-Type | Latch
U-type | Identical |
| Patient contact
surfaces | Brass with Nickel Chrome
Plating | Brass and Nickel
Chrome Plating | Identical |
| Heat generate
after 5 minutes
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
40,000 rpm & U-Type contra
angle 20,000 rpm | Model
DC-20L | |
| Indications of use | The U-Type Contra Angles and
U-Type Sectional contra angles
are used to mount on U-Type
Nose Attachments and powered | ND u-type prophylaxis
angle is use to
mounted on U-type
nose attachment | Similar |
| 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. | | | powered by either low
speed air motor or
electric micro motor
for hygiene dentistry
work. All devices are
fully Autoclavable. |
| Technical characteristic | | | |
| Body length | 3.100" | 3.110" | similar |
| Weight | 32.9g | 35.0g | similar |
| Bearing type | Precision ball bearings | Phosphor Bronze
bushing bearings | Precision Ball bearings
can performance better
and less friction (less
heat generating)
compare to Phosphor
Bronze bushing
bearings |
| Speed
range | 0-40,000 rpm | 0-20,000 rpm | Precision ball bearing
can handle higher
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
surfaces | Brass with Nickel Chrome
Plating | Brass and Nickel
Chrome Plating | identical |
| Heat generate
after 5 minutes
free run | From 21 °C to 27°C | From 21 °C to 29°C | Similar |
| | U-Type Contra angle Friction
Grip 20,000 rpm | Model
DC-10FG | |
| Indications of 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. | ND u-type prophylaxis
angle is use to
mounted on U-type
nose attachment
powered by either low
speed air motor or
electric micro motor
for hygiene dentistry
work. All devices are
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
bushing bearings | Precision Ball bearings
can performance better
and less friction (less) |
| | | | |
| | | | heat generating)
compare to Phosphor
Bronze bushing
bearings |
| Speed range | 0-20,000 rpm | 0-15,000 rpm | Precision ball bearing
can 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
surfaces | Brass with Nickel Chrome
Plating | Brass and Nickel
Chrome Plating | identical |
| Heat generate
after 5 minutes
free run | From 21 °C to 29.7°C | From 21 °C to 29.7°C | Identical |
| | | | |
| | U-Type Sectional Contra angle
Friction Grip 20,000 rpm | Model
DC-20FG | |
| Indications of use | The U-Type Contra Angles and
The 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. | ND u-type prophylaxis
angle is use to
mounted on U-type
nose attachment
powered by either low
speed air motor or
electric micro motor
for hygiene dentistry
work. All devices are
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
bushing bearings | Precision Ball bearings can
performance better and
less friction (less heat
generating) compare to
Phosphor Bronze bushing
bearings |
| Speed range | 0-20,000 rpm | 0-15,000 rpm | Precision ball bearing can
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
surfaces | Brass with Nickel Chrome
Plating | Brass and Nickel
Chrome Plating | identical |
| Heat generate
after 5 minutes
free run | From 21 °C to 28.1°C | From 21 °C to
28.1°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.