(34 days)
Not Found
No
The description focuses on the material properties, manufacturing, and packaging of dental files, with no mention of AI or ML.
Yes
The device is used to file and shape root canals and remove necrotic tissue, which are actions consistent with therapeutic interventions for dental treatment.
No
The device is used to file and shape root canals and remove necrotic tissue, which are treatment procedures, not diagnostic functions.
No
The device description clearly describes physical instruments (files and instruments cut from a nickel titanium shaft with plastic handles) used for shaping root canals, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states the device is used to "file and shape root canals and to remove necrotic tissue." This is a surgical or procedural function performed inside the patient's body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is purely mechanical manipulation within the root canal.
Therefore, based on the provided information, this device falls under the category of a dental instrument used for a therapeutic procedure, not an IVD.
N/A
Intended Use / Indications for Use
STERILE SUREFLEX® FILES AND INSTRUMENTS are used to file and shape root canals and to remove necrotic tissue as a means to create a funnel-shaped cavity.
Product codes (comma separated list FDA assigned to the subject device)
EFA
Device Description
STERILE SUREFLEX® FILES AND INSTRUMENTS are manufactured for DENTSPL.Y Caulk by DENTSPLY Maillefer®. They are identical to the Presterilized SureFlex® files and instruments now marketed (K951607). However, DENTSPLY Caulk plans to market these devices as sterile and to revise the labeling to reflect this change. There are no changes to the composition, manufacturing process, or sterilization process.
STERILE SUREFLEX® FILES AND INSTRUMENTS are precision instruments cut from a nickel titanium shaft for increased flexibility over stainless steel instruments. They conform better to the curved surface of most root canals. They reduce the chance of apical transportation and breakage from binding in the canal. They feature non-slip plastic handles for a firmer grip, as well as ISO color coding for easy identification.
After sterilization, these files and instruments presented the same resistance in torsion and shear stress as non-sterilized instruments. No significant change in color or mechanical behavior of the plastic handles was evident following gamma irradiation.
The device package is a compartmentalized container with six (6) individually separated cells. The package includes a heat-sealed non-tearing perforated thermal adhesive strip. This strip allows for a single cell to be opened per file as required by the dentist, while all other file cells remain sealed and sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist
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)
These files and instruments were subjected to sterilization by gamma irradiation from a Cobalt 60 source. The validation method used was AAMI Method 1.
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.
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
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 ax (717) 854-2343-
P. J. Lehn Telefax (717) 849-4343
CONTACT: P. Jeffery Lehn
4 1997 II IN
DATE PREPARED: April 29, 1977
TRADE OR PROPRIETARY NAME: STERILE SUREFLEX® FILES AND INSTRUMENTS
COMMON OR USUAL NAME: Files and Instruments
CLASSIFICATION NAME: Dental hand instruments 872.4565
K951607 LEGALLY MARKETED DEVICE: Presterilized SureFlex® Files
DEVICE DESCRIPTION: STERILE SUREFLEX® FILES AND INSTRUMENTS are manufactured for DENTSPL.Y Caulk by DENTSPLY Maillefer®. They are identical to the Presterilized SureFlex® files and instruments now marketed (K951607). However, DENTSPLY Caulk plans to market these devices as sterile and to revise the labeling to reflect this change. There are no changes to the composition, manufacturing process, or sterilization process.
STERILE SUREFLEX® FILES AND INSTRUMENTS are precision instruments cut from a nickel titanium shaft for increased flexibility over stainless steel instruments. They conform better to the curved surface of most root canals. They reduce the chance of apical transportation and breakage from binding in the canal. They feature non-slip plastic handles for a firmer grip, as well as ISO color coding for easy identification.
After sterilization, these files and instruments presented the same resistance in torsion and shear stress as non-sterilized instruments. No significant change in color or mechanical behavior of the plastic handles was evident following gamma irradiation.
INTENDED USE: STERILE SUREFLEX® FILES AND INSTRUMENTS are used to file and shape root canals and to remove necrotic tissue as a means to create a funnel-shaped cavity.
TECHNOLOGICAL CHARACTERISTICS: As noted above, there are no changes in the composition, manufacturing or sterilization of these files and instruments.
These files and instruments were subjected to sterilization by gamma irradiation from a Cobalt 60 source. The validation method used was AAMI Method 1.
The device package is a compartmentalized container with six (6) individually separated cells. The package includes a heat-sealed non-tearing perforated thermal adhesive strip. This strip allows for a single cell to be opened per file as required by the dentist, while all other file cells remain sealed and sterile.
We believe that the fact that the new device is identical to the predicate device, along with the sterilization data presented, supports the safety and effectiveness of STERILE SUREFLEX® FILES AND INSTRUMENTS for the intended uses.
000010
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 1997
Mr. P. Jeffrey Lehn ·Director, Corporate Compliance and Regulatory Affairs Baxter Healthcare Corporation DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872 :44
K971603 Re : Sterile Sureflex® Files and Instruments Trade Name: Requlatory Class: I Product Code: EFA Dated: April 29, 1997 Received: May 01, 1997
Dear Mr. Lehn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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11 2017 11:40
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301). 443-6597.
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109) .....
510(K) Number:
Device Name:
STERILE SUREFLEX® FILES AND INSTRUMENTS
Indications for Use:
Used to file and shape root canals and to remove necrotic tissue as a means to create a funnel-shaped cavity.
Susan Plassman
Concurrence of CDRH, Office of Device Evaluation (ODE) (Divisio 510k) ાર
Over-The-Counter Use __
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