(303 days)
Not Found
No
The 510(k) summary describes a mechanical accessory (ultrasonic tips) made of stainless steel for use with an existing ultrasonic handpiece. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The description focuses solely on the physical characteristics and intended use of the tips.
No
The device aids in a medical procedure performed by a professional but is not inherently therapeutic. It's a tool for removal of tissue and blockages, not a device that directly treats a condition or provides therapy.
No
Explanation: The device is described as an accessory for removing soft and hard tissue, endodontic posts, and intra-canal blockages during root canal preparation procedures. It is a therapy device, not a diagnostic one.
No
The device description explicitly states that the device is made from stainless steel and is an accessory to a handpiece and scaler unit, indicating it is a physical hardware component.
Based on the provided information, this device 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.
- Device Function: The tün® ultrasonic tips are described as accessories used during dental procedures (endodontic root canal preparation, post removal, blockage removal). They are physical tools used to manipulate tissue and materials within the tooth.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens taken from the patient. Its function is mechanical and procedural.
Therefore, the tün® ultrasonic tips fall under the category of a surgical or procedural dental device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
tün® ultrasonic tips are intended for use by dental professionals for the removal of soft and hard tissue during endodonic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages.
Product codes
ELC
Device Description
tün® ultrasonic tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. The tün® ultrasonic tips are made from 17-4ph Stainless Steel. Alloy 17-4ph (UNS S17400), Type 630, is a chromium-nickel-copper precipitation-hardening martensitic stainless steel with an addition of niobium. The tips will be available in M3xO.5 and M3x0.6 thread with 6 different tip designs. 1 tip design is devised for post removal; the remaining 5 tips are designed for negotiating the various angles and directions of root canals. Certain models have diamond (zirconium nitride) coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended User(s): Dentists, Endodontists, Oral surgeons, and Dental hygienists
Intended Use Environment: In dental clinics
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)
Not Found
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
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 7, 2019
Engineered Endodontics % John Ziobro Principal Consultant SpectraMedEx, LLC 3215 Golf Road #1459 Delafield, Wisconsin 53018
Re: K182145
Trade/Device Name: tün® ultrasonic tips product family Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: April 24, 2019 Received: May 1, 2019
Dear John Ziobro:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Malvina B Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182145
Device Name tün® ultrasonic tips product family
Indications for Use (Describe)
tim® ultrasonic tips are intended for use by dental professionals for the removal of soft and hard tissue during endodonic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
tün® ultrasonic tips Product Family TRADIONAL 510(K) SUMMARY
Section 3
K182145 Traditional 510(k) Summarv
-
- Summary Date: June 1, 2018
- Applicant Name: Engineered Endodontics, LLC 2. W134 N4965 Campbell Drive Menomonee Falls, WI 53051 Establishment Registration Number: 3012322979
-
- Submission Correspondent: On behalf of Engineered Endodontics, the following consultant is assigned the responsibility of submission correspondence:
John F. Ziobro, Principal Consultant SpectraMedEx, LLC 3215 Golf Road, #149 Delafield, WI 53018 Ph: 262.719.8922
-
- Trade Name: tün® ultrasonic tips product family
- న. Common Name: Scaler, Ultrasonic
-
- Description:
tün® ultrasonic tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. The tün® ultrasonic tips are made from 17-4ph Stainless Steel. Alloy 17-4ph (UNS S17400), Type 630, is a chromium-nickel-copper precipitation-hardening martensitic stainless steel with an addition of niobium. The tips will be available in M3xO.5 and M3x0.6 thread with 6 different tip designs. 1 tip design is devised for post removal; the remaining 5 tips are designed for negotiating the various angles and directions of root canals. Certain models have diamond (zirconium nitride) coating.
-
- Manufacturing Site: Engineered Endodontics, LLC W134 N4965 Campbell Drive Menomonee Falls, WI 53051 Establishment Registration Number: 3012322979
-
- Classification Regulation, Class, Product Code, Description & Panel:
| Regulation # | Class | ProCode | Description | Panel |
|---|---|---|---|---|
| 21CFR872.4850 | II | ELC | Scaler, Ultrasonic | Dental |
Predicate Device(s): Predicate: 9.
510(k) Number: K132609 ESSENTIAL DENTAL SYSTEMS, INC. Manufacturer: 89 Leuning Street, Suite 8 South Hackensack, NJ 07606 Trade Name: EDS ULTRASONIC TIPS Classification Regulation, Class, Product Code, Description & Panel:
| Regulation # | Class | ProCode | Description | Panel |
|---|---|---|---|---|
| 21CFR872.4850 | II | ELC | Scaler, Ultrasonic | Dental |
tün® ultrasonic tips Product Family Traditional 510(k) Submission
4
-
- Proposed Indication for Use:
tün® ultrasonic tips are intended for use by dental professionals for the removal of soft and hard tissue during endodontic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages.
- Proposed Indication for Use:
-
- Compliance to Special Controls / Performance Standards: Compliance to the following recognized consensus standards is declared:
- ISO 7405 Second edition 2008-12-15 Dentistry Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)]. The application of this standard resulting in testing to:
- ISO 10993-5:2009 / (R) 2014 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2009 / (R) 2014 Biological Evaluation of Medical Devices-Part 10: Tests for irritation and skin sensitization
- ISTA 3A General Simulation Performance Test Procedure: Packaged- Products for Parcel Delivery System Shipment 150lbs or less
-
- Technological Characteristics
The proposed device is similar to the predicate device and as substantially equivalent technological characteristics.
-
- Comparison to Predicates
The main differences between the tün® ultrasonic tips under review and the predicate device cleared under K132609 are as follows:
- Comparison to Predicates
-
The proposed device is plated while the predicate device is not. This difference is a function of the manufacturing method and does not affect the overall safety or performance of the device. Note: The predicate device chosen by EDS that cleared under K960889 used Titanium Nitride as plating materials.
-
The proposed device is manufactured by sintering while the predicate device is machined. The end result ● from either method are ultrasonic tips with similar geometries and identical intended uses. The different manufacturing methods simply reflect the in-house equipment / manufacturing capabilities of the two different companies and do not affect the overall safety or performance of the device.
-
. The proposed device uses a Chromium:Nickel:Copper stainless steel alloy, while the predicate device uses a Chromium:Nickel:Molybdenum stainless steel. The materials were chosen based on the manufacturing methods and do not affect the overall safety or performance of the device.
-
The proposed device offers 6 variants; the predicate device offers 6 variants, but there isn't an exact 1:1 matchup and the overall sizes and weights are slightly different. However, these differences do not raise any new questions of safety or effectiveness.
The minor differences between the ultrasonic tips under review and the predicate device cleared under K132609 are as follows:
- The proposed device consistently references the ISO standard for thread sizes to interface with the ultrasonic ● generators (M3x0.5 or M3x0.6 thread), while the predicate device references one ISO and one American standard (M3x0.5 and #5-40 thread).
- The proposed device explicitly states the intended users, the intended use environment, the targeted patient . population, the operating & storage temperatures, compliance to specific standards, etc. while the predicate device does not.
The proposed device states that they are to be "used on piezo ultrasonic endodontic and scaler units which operate in the range of 20,000hz - 35,000hz," while the predicate device states that they vibrate "at high frequencies (up to 40,000 Hz)."
A table showing substantial equivalence to the predicate device follows:
5
Image /page/5/Picture/0 description: The image shows the words "engineered endodontics" in green font. The word "engineered" is on the top line, and the word "endodontics" is on the bottom line. The words are in a sans-serif font and are outlined in a light gray color. There is a registered trademark symbol to the right of the word "endodontics".
tün® ultrasonic tips Product Family TRADIONAL 510(K) SUMMARY
Volume 2
Section 3
| | Proposed Device: tün® ultrasonic tips
Product Family | Predicate Device: EDS Ultrasonic Tips
K132609 | |
|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | | | Comments |
| COMPARISON OF GENERAL INFORMATION / USES & INDICATIONS | | | |
| Photograph | Image: tün® ultrasonic tips | Image: EDS Ultrasonic Tips | For Information Purposes only, but the images show
that the Proposed Device is Substantially Equivalent
in its overall shape/configurations to the predicate
device. |
| FDA Product Code | ELC | ELC | Identical to the predicate.
Therefore, Substantially Equivalent |
| FDA Regulation Number | 872.4950 | 872.4950 | Identical to the predicate.
Therefore, Substantially Equivalent |
| FDA Regulation Class | Class II | Class II | Identical to the predicate.
Therefore, Substantially Equivalent |
| FDA Regulation
Description | Scaler, Ultrasonic | Scaler, Ultrasonic | Identical to the predicate.
Therefore, Substantially Equivalent |
| Intended Use /
Indication for Use
(As statement appears in the
510(k) indications for use
form) | tün® ultrasonic tips are intended for use by dental
professionals for the removal of soft and hard tissue
during endodontic root canal preparation procedures.
They can also aid in the removal of endodontic posts and
other intra-canal blockages. | EDS Ultrasonic Tips are intended for use by dental
professionals for the removal of soft and hard tissue during
endodontic root canal preparation procedures. They can
also aid in the removal of endodontic posts and other intra-
canal blockages. | Except for branding issues (tün® versus EDS), the
Indication for Use statements are identical. Branding
does not raise any new questions of safety of
effectiveness.
Therefore, Substantially Equivalent |
| FDA Device Description
(As it appears in the
applicable FDA Summary
Statement) | tün® ultrasonic tips are an accessory to a piezoelectric
ultrasonic handpiece and scaler unit. These powered
components are not included as part of the device
submitted for application with the 510(k) submission.
tün® ultrasonic tips are stainless steel and will be
available in M3x0.5 and M3x0.6 thread with 6 different
tip designs. 1 tip design is devised for post removal; the
remaining 5 tips are designed for negotiating the various
angles and directions of root canals. | EDS Ultrasonic Tips are an accessory to a piezoelectric
ultrasonic handpiece and scaler unit. These powered
components are not included as part of the device
submitted for application with the 510(k) submission. EDS
Ultrasonic Tips are stainless steel and will be available in
M3x0.5 and #5-40 thread with 6 different tip designs. 1 tip
design is devised for post removal; the remaining 5 tips are
designed for negotiating the various angles and directions
of root canals. | Except for branding issues (tün® versus EDS), and
the use of thread standards (M3x0.6 vs #5-40), the
Device Descriptions are identical. The proposed
device consistently references the ISO standard for
thread sizes, while the predicate device references one
ISO and one American standard). Branding issues and
citing different but equivalent standards for thread
sizes do not raise any new questions of safety of
effectiveness.
Therefore, Substantially Equivalent |
| Intended User(s) | Dentists, Endodontists, Oral surgeons, and Dental
hygienists | Although not formally stated, assumed to be Dentists,
Endodontists, Oral surgeons, and Dental hygienists | Although not known to be formally stated in the
predicate's submission, the intended users are
assumed to be identical to the predicate. |
| | Proposed Device: tün® ultrasonic tips
Product Family | Predicate Device: EDS Ultrasonic Tips
K132609 | |
| Item | | | Comments |
| Intended Use
Environment | In dental clinics | Although not formally stated, assumed to be dental clinics | Therefore, Substantially Equivalent
Although not known to be formally stated in the
predicate's submission, the Intended Use Environment
is assumed to be identical to the predicate.
Therefore, Substantially Equivalent |
| Contra-Indication(s) | There are no known contra-indications when used as
recommended. | There are no known contra-indications when used as
recommended. | Identical to the predicate.
Therefore, Substantially Equivalent |
| Warnings | Please refer to the instructions for use of the manufacturer of
the piezoelectric ultrasonic unit. It is important to note that
the different | Please refer to the instructions for use of the manufacturer of
the piezoelectric ultrasonic unit. It is important to note that the
different | Identical to the predicate.
Therefore, Substantially Equivalent |
| Precautions | • Do not start the piezoelectric ultrasonic generator with
damaged ultrasonic tips.
• For best results, and your safety, the use of a visual
aid is recommended.
• Do not heat above 275°F/135°C.
• Tips that have been distorted in any fashion should be
discarded.
• To avoid overheating the dentin structures, do not
apply continuous contact for more than 30 seconds.
• The tip must be tightened onto the ultrasonic handpiece
prior to use. Please pay attention not to over tighten nor
under tighten. | • Do not start the piezoelectric ultrasonic generator with
damaged ultrasonic tips.
• For best results, and your safety, the use of a visual aid is
recommended.
• Do not heat above 275°F/135°C.
• Tips that have been distorted in any fashion should be
discarded.
• To avoid overheating the dentin structures, do not apply
continuous contact for more than 30 seconds.
• The tip must be tightened onto the ultrasonic handpiece
prior to use. Please pay attention not to over tighten nor
under tighten. | Identical to the predicate.
Therefore, Substantially Equivalent |
| | | COMPARISON OF STERILIZATION ISSUES | |
| Sterilization Status | Provided non-sterile. | Provided non-sterile. | Identical Sterilization Status.
Therefore, Substantially Equivalent |
| Sterilization Instructions | tün ultrasonic tips are not sold sterile and must be
cleaned and sterilized prior to each use.
A. Wipe tips with a cleaning disinfectant.
B. Cleaning -
Pre-clean using a high-quality, pH neutral, ultrasonic
cleaning solution. Follow solution manufacturer's
instructions.
Dry thoroughly with a towel and compressed air.
C. Steam Sterilization -
Place the tips to be sterilized in an autoclave pouch
prior to sterilization. | EDS Ultrasonic Tips are not sold sterile and must be
cleaned and sterilized prior to each use.
A. Wipe tips with a cleaning disinfectant.
B. Cleaning -
Pre-clean using a high-quality, pH neutral, ultrasonic
cleaning solution. Follow solution manufacturer's
instructions.
Dry thoroughly with a towel and compressed air.
C. Steam Sterilization -
Place the tips to be sterilized in an autoclave pouch
prior to sterilization. | Except for branding issues (tün® versus EDS), the
Sterilization Instructions are identical. Branding does
not raise any new questions of safety of effectiveness.
Therefore, Substantially Equivalent |
| Sterilization Parameters | Gravity Steam Sterilizer:
• Temperature: 250° F/121° C.
• Cycle Time: 30 minutes
• Maximum Dry Time: 30 minutes
Prevacuum Steam Sterilizer: | Gravity Steam Sterilizer:
• Temperature: 250° F/121° C.
• Cycle Time: 30 minutes
• Maximum Dry Time: 30 minutes
Prevacuum Steam Sterilizer: | Identical Sterilization Parameters.
Therefore, Substantially Equivalent |
VOL 002/009 VOL 002 003 Traditional 510(k) Summary - REVISED 2.docx tün® ultrasonic tips Product Family Traditional 510(k) Submission Confidential Page 002/003-3
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Image /page/6/Picture/0 description: The image shows the words "engineered endodontics" in green font. The word "engineered" is on the top line, and the word "endodontics" is on the bottom line. There is a registered trademark symbol to the right of the word "endodontics". The background is white.
tün® ultrasonic tips
Volume 2
Section 3
| tün® ultrasonic tips Product Family
Traditional 510(k) Submission | Confidential | VOL 002/009 VOL 002 003 Traditional 510(k) Summary - REVISED 2.docx
Page 002/003-4 |
| ---------------------------------------------------------------------- | -------------- | --------------------------------------------------------------------------------------- |
|---|
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Image /page/7/Picture/0 description: The image contains the words "engineered endodontics" in a stylized font. The words are stacked on top of each other, with "engineered" on the top line and "endodontics" on the bottom line. The text is green with a light gray outline. There is a registered trademark symbol next to the word "endodontics".
tün® ultrasonic tips
Volume 2
Section 3
| | Proposed Device: tün® ultrasonic tips
Product Family | | | Predicate Device: EDS Ultrasonic Tips
K132609 | | Comments |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | • Temperature: 270° F/132° C. | | | • Temperature: 270° F/132° C. | | |
| | • Cycle Time: 4 minutes | | | • Cycle Time: 4 minutes | | |
| | • Maximum Dry Time: 30 minutes | | | • Maximum Dry Time: 30 minutes | | |
| | | | | | | |
| Operating Principle | tün tips interact with piezo ultrasonic hand piece and
unit. tün tips are an accessory to a piezo ultrasonic hand
piece and unit.
tün tips are used on piezo ultrasonic endodontic and
scaler units which operate in the range of 20,000hz –
35,000hz. | | COMPARISON OF OPERATING PRINCIPLES & MATERIALS
Used in conjunction with piezoelectric ultrasonic handpiece
and scaler. Ultrasonic energy vibrates tip at high
frequencies (up to 40,000 Hz) | | | Identical Operating Principles with similar operational
ranges.
Therefore, Substantially Equivalent |
| Comparison of Tip Shapes | Tip
Shape
E1 Radiused Tip with diamond
E2 Radiused Tip without diamond
E3 Ball Tip
E4 Football Tip
E5 Disc-Shaped Tip
E6 Short, Robust Tip | EDS Tip
EDS 2/3
EDS 2/3
EDS 4
EDS 4
EDS 5
EDS 1 | Tip
EDS 1
EDS 2
EDS 3
EDS 4
EDS 5
EDS 6
Equivalent | Shape
Short, Robust Tip
Radiused Tip
Radiused Tip II
Large Point Tip
Small Pointed Tip
N/A - Irrigation Tip | tün Tip
E6
E1/2
E1/2
E3/4/5
E1/2
No Direct | Both the predicate device and the proposed device
offer the various tip shapes that are commonly used in
the industry. The differences in tip shape do not
introduce any new questions of safety or
effectiveness.
Therefore, Substantially Equivalent |
| Construction Materials | 17-4ph Stainless Steel
Alloy 17-4PH (UNS S17400), Type 630, is a chromium-
nickel-copper precipitation-hardening martensitic
stainless steel with an addition of niobium. 17-4PH
combines high strength and hardness with good
corrosion resistance. | | 316 Stainless Steel
Alloy 316/316L (UNS S31600/ S31603) is a chromium-
nickel- molybdenum austenitic stainless steel developed to
provide improved corrosion resistance to Alloy 304/304L
in moderately corrosive environments. It is often utilized in
process streams containing chlorides or halides. The
addition of molybdenum improves general corrosion and
chloride pitting resistance. It also provides higher creep,
stress-to-rupture and tensile strength at elevated
temperatures. | | | The proposed device uses a Chromium:Nickel:
Copper stainless steel alloy, while the predicate device
uses a Chromium:Nickel:Molybdenum stainless steel
alloy. The difference in materials reflect different
manufacturing methods (sintering versus machining)
and does not affect the overall safety or performance
of the finished device.
Therefore, Substantially Equivalent |
| Coatings | Nickel Plating or
Diamond Nickel Plating | | None | | | The proposed device is plated while the predicate
device is not. This difference is a function
manufacturing method and does not affect the overall
safety or performance of the device. Note: The
predicate device chosen by K132609 used
Titanium Nitride and Zirconium Nitride as plating
materials - see K960889.
Therefore, Substantially Equivalent |
| | | | | COMPARISON OF CLINICAL USE / INTERACTIONS WITH OTHER DEVICES | | |
| Interaction with other
products and/or items
used with the product | tün instruments have been designed to function on most
brands of Piezo-Electric type dental ultrasonic Scalers
that use an M3x0.5 or M3x0.6 thread. Refer to your | | | EDS Ultrasonic Tips are an accessory to a piezoelectric
ultrasonic handpiece and scaler unit with M3x0.5 or #5-40
threads | | Both devices require the use of third-party ultrasonic
scalers. These devices use one of two thread types
either M3x0.5 or M3x0.6/#5-40. Functionally, the |
| tün® ultrasonic tips Product Family | VOL_002/009 VOL_002_003_Traditional 510(k) Summary - REVISED 2.docx | |
|---|---|---|
| Traditional 510(k) Submission | Confidential | Page 002/003-5 |
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Image /page/8/Picture/0 description: The image shows the words "engineered endodontics" stacked on top of each other. The words are in a green sans-serif font with a light gray outline. The word "engineered" is on top, and the word "endodontics" is below it. There is a registered trademark symbol to the right of the word "endodontics".
tün® ultrasonic tips Product Family TRADIONAL 510(K) SUMMARY
Volume 2
Section 3
| Item | Proposed Device: tün® ultrasonic tips
Product Family | Predicate Device: EDS Ultrasonic Tips
K132609 | Comments |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ultrasonic machine owner's manual for further details on
the use of these types of devices. | | devices are same.
Therefore, Substantially Equivalent |
| COMPARISON OF PACKAGING SPECIFICATIONS / CONFIGURATIONS | | | |
| Catalog Numbering | The catalog number schema uniquely identifies each
variant as tun-e-X or tun-e-Xe
Where e-X = Satelec type threads and X = the tip style
from 1 to 6
And e-Xe = EMS type threads and X = the tip style from
1 to 6. | The catalog number schema uniquely identifies each
variant as 610-XX or 615-XX
Where 610 = E type threads; 615 = M type threads
And XX = the tip style from 01 to 06.
Image: 610-xx E-Threads Fit These Units:
Image: 615-xx M-Threads Fit These Units: | Both the proposed and predicate devices offer a total
series of 6 tips that use two different thread styles for
a total of 12 different tips. The proposed devices call
M3x0.6 threads "Satelec" style, while the predicate
calls them "E" style and proposed devices calls
M3x0.5 threads "E" style, while the predicate calls
them "M" style. Both devices use a formulaic catalog
numbering system to encode for the 12 variants.
Although the systems are different, no new issues of
safety or effectiveness are introduced.
Therefore, Substantially Equivalent |
| Packaging Configurations | Sold as individual tips | Sold as individual tips | Identical to the predicate.
Therefore, Substantially Equivalent |
| Packaging Materials | Plastic tray | Plastic pouch | Identical to the predicate.
Therefore, Substantially Equivalent |
| COMPARISON OF DIMENSIONAL SPECIFICATIONS | | | |
| Dimensions | Each tip is approximately 12 mm long by 14 mm wide | Each tip is approximately 15 mm long by 20 mm wide | Similar overall dimensions. The minor variations do
not introduce any new questions of safety or
effectiveness. Therefore, Substantially Equivalent |
| Weight | Each tip weighs approximately 0.75 grams. | Each tip weighs approximately 1.2 grams. | Similar weight. The minor variations do not introduce
any new questions of safety or effectiveness.
Therefore, Substantially Equivalent |
| COMPARISON OF ENVIRONMENT SPECIFICATIONS | | | |
| Operating Environment | Room Temperature | Not Known | Although the predicate device did not state its
operating environment, the proposed device's
operating environment does not raise any new
questions of safety or effectiveness.
Therefore, Substantially Equivalent |
| Storage Environment | Room Temperature | Not indicated | Although the predicate device did not state its storage
environment, the proposed device's storage
environment does not raise any new questions of
safety or effectiveness.
Therefore, Substantially Equivalent |
| COMPARISON OF APPLIED STANDARDS | | | |
| | Proposed Device: tün® ultrasonic tips
Product Family | Predicate Device: EDS Ultrasonic Tips
K132609 | |
| Item
Applicable Standards | • ISO 7405 Second edition 2008-12-15 Dentistry -
Evaluation of biocompatibility of medical devices
used in dentistry [Including: Amendment 1 (2013)]
resulting in testing to:
• ISO 10993-5:2009 / (R) 2014 Biological
Evaluation of Medical Devices-Part 5: Tests for in
vitro cytotoxicity
• ISO 10993-10:2009 / (R) 2014 Biological
Evaluation of Medical Devices-Part 10: Tests for
irritation and skin sensitization
• ISTA 3A General Simulation Performance Test
Procedure: Packaged - Products for Parcel Delivery
System Shipment 150lbs or less | Not indicated / not known/cited | ISO 7405 Second edition is a recognized consensus
standard for product code ELC and ISTA 3A is a
widely used standard for evaluating
packaging/shipping performance. The Summary
Statement of the predicate device did not cite the use
of any external standards. However, the proposed
device's compliance with the cited standards only
bolsters the argument for safety and effectiveness.
Therefore, Substantially Equivalent |
VOL 002/009 VOL 002 003 Traditional 510(k) Summary - REVISED 2.docx tün® ultrasonic tips Product Family Traditional 510(k) Submission Confidential Page 002/003-6
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Image /page/9/Picture/0 description: The image shows the words "engineered endodontics" stacked on top of each other. The words are in a green sans-serif font with a white outline. The word "engineered" is on the top line, and the word "endodontics" is on the bottom line. There is a registered trademark symbol to the right of the word "endodontics".
tün® ultrasonic tips Product Family TRADIONAL 510(K) SUMMARY
Volume 2
Section 3
- Comparison Summary / Conclusions
Engineered endodonics believes the proposed tine predicate, the EDS ultrasonic tips, cleared under K132609, are substanially equivalent in their intended users, intended use environment and indications for use. Furthermore, both devices have the samelequivalent technological characteristics and applicable safety standards. The differences that exist between the devices, relating to their manufacturing methods, coatings and minor shape variations are not significant and are therefore substantially equivalent.
| tün® ultrasonic tips Product Family | VOL_002/009 VOL_002_003 Traditional 510(k) Summary - REVISED 2.doc | |
|---|---|---|
| Traditional 510(k) Submission | Confidential | Page 002/003- |