(288 days)
K#962540
Not Found
No
The description focuses on a mechanical handpiece for root canal procedures and does not mention any AI or ML components or functionalities.
No
The device is used for shaping and obturation of the root canal, which are procedural steps rather than a direct therapeutic effect on a disease or condition. The device facilitates mechanical preparation but doesn't independently treat or diagnose.
No
The device, "Endo-Express® Handpiece," is indicated for the removal of dentin, shaping, and obturation of the root canal, which are therapeutic and procedural actions, not diagnostic ones.
No
The device description clearly states it is a "reciprocating handpiece" and includes physical components like a handpiece, lubricant bottle, and nozzle attachment. It is a hardware device used in dental procedures.
Based on the provided information, the Endo-Express® Handpiece is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Endo-Express® Handpiece function: The description clearly states its intended use is for the mechanical preparation of root canals within the patient's body. It's a tool used directly on the patient's anatomy during a dental procedure.
Therefore, the Endo-Express® Handpiece falls under the category of a surgical or procedural device, not an IVD.
N/A
Intended Use / Indications for Use
Endo-Express® Handpiece is indicated for the removal of dentin, shaping and obturation of the root canal. This application area extends to endodontic procedures using NiTi or stainless steel endodontic instruments intended by the manufacturer for use in the mechanical preparation of root canals.
Product codes
EGS
Device Description
Endo-Express® Handpiece is a reciprocating handpiece for use with NiTi or stainless steel instruments during endodontic procedures. The handpiece is driven by an air motor. The steps required to properly operate the handpiece are: push button to open chuck, insert instrument handle into chuck, release button to close chuck, run handpiece. After use, the handpiece should be lubricated and autoclaved.
The contents of the kit are
- 1 Endo-Express® Handpiece
- 1 Lubricant bottle
- 1 nozzle attachment
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Applicable
Key Metrics
Not Found
Predicate Device(s)
K#962540
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 1 6 2012
Exhibit #1
510(k) SUMMARY
ﺎ
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K111541.
Submitter's Identification: 1.
Essential Dental Systems
- 89 Leuning Street
- South Hackensack, NJ 07606
- Date Summary Prepared: June 18, 2011
- Date Summary Revised: February 13th, 2012
- Contact: Mr. Jeffrey Wan
- Contact Phone #: 201-487-9090 ext. 118
- Contact Fax #: 201-487-5120
2. . Name of the Device:
:
:
:
: --
.
:
Trade name: Endo-Express® Handpiece
- Common name: dental handpiece
- Classification name: dental handpiece (21 CFR 872.4200, Product Code EGS)
3. Predicate Device Information:
-
- TEP E4R, K#962540, NSK Nakanishi, Tochigi, Japan
4. · Device Description:
Endo-Express® Handpiece is a reciprocating handpiece for use with NiTi or stainless steel instruments during endodontic procedures. The handpiece is driven by an air motor. The steps required to properly operate the handpiece are: push button to open chuck, insert instrument handle into chuck, release button to close chuck, run handpiece. After use, the handpiece should be lubricated and autoclaved.
The contents of the kit are
- 1 Endo-Express® Handpiece
- 1 Lubricant bottle
- 1 nozzle attachment
1
5. Intended Use:
.
.
r
ー・・・・
·
Endo-Express® Handpiece is indicated for the removal of dentin, shaping and obturation of the root canal. This application area extends to endodontic procedures using NiTi or stainless steel endodontic instruments intended by the manufacturer for use in the mechanical preparation of root canals.
6. Comparison to Predicate Devices:
The subject device is similar to the TEP E4R in that they are both 90³ reciprocating handpieces used in conjunction with various endodontic instrumentation systems for the treatment of root canals. The directions for use for these materials are nearly identical.
The subject device differs from the TEP E4R in cosmetic appearance and the max allowable motor speed.
| Characteristic | Endo-Express® | TEP E4R |
|---|---|---|
| Max Motor Speed | $12,000min^{-1}$ | $40,000min^{-1}$ |
| Latch Type | Push Button Chuck | Push Button Chuck |
| File Type | hand files | hand files |
| Motor Connection | E-Type air or electric motor | E-Type air or electric motor |
| Reduction Ratio | 4:1 | 4:1 |
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as Follows:
Not Applicable
Discussion of Clinical Tests Performed: 8.
Not Applicable
9. Conclusions:
Endo-Express® Handpiece has the same intended use and similar technological characteristics as the predicate device. Thus, Endo-Express® Handpiece is substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 6 2012
Mr. Jeffrey Wan Research and Development Manager Essential Dental Systems, Incorporated 89 Leuning Street, Suite 8 South Hackensack, New Jersey 07606
- Re: K111541
Trade/Device Name: Endo Express® Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: March 7, 2012 · Received: March 8, 2012
Dear Mr. Wan:
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.
3
Page 2- Mr. Wan
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
h fac
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit B
Indications for Use
Page 1 of 1
510(k) Number (if known): K111541
Device Name: Endo Express® Handpiece
Indications for Use:
Endo-Express® Handpiece is indicated for the removal of dentin, shaping and obturation of the root canal. This application area extends to endodontic procedures using NiTi or stainless steel endodontic instruments intended by the manufacturer for use in the mechanical preparation of root canals.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over the Counter Use (Per 21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pearson
(Division Sign-Off) (Division Olgh Olyn of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K111541