(258 days)
No
The device description and performance studies focus on the physical properties and mechanical function of ultrasonic scaler tips, with no mention of AI or ML.
Yes.
The device is used for dental cleaning, periodontal therapy, and endodontic applications, all of which aim to treat medical conditions.
No
The device is an ultrasonic scaler tip, used for removing calculus and cleaning root canals. These are therapeutic and maintenance functions, not diagnostic ones.
No
The device description explicitly states the device is made from Stainless Steel and Nickel Titanium Alloy, indicating it is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove calculus and stain from teeth and clean/irrigate root canals. These are procedures performed directly on the patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description: The device is an accessory to an ultrasonic handpiece and scaler unit used for physical removal of deposits and preparation of teeth/root canals. It does not analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, urine, or any other biological sample. The device's function is mechanical and physical.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ultrasonic scaler tips are intended for use by dental professionals to:
- Remove supra and sub gingival calculus deposits and stain from the teeth;
- Clean and irrigate root canals.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
Ultrasonic scaler tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. The devices are used during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodontic applications to prepare the teeth and/or root of the teeth for repair.
The models are GD1, GD2, GD4, GD5, GD6, PD1, PD3, PD4, PD4D, ED1. The Ultrasonic scaler tips are made from Stainless Steel 30Cr13 and the endo files are made of Nickel Titanium Alloy. The tips will be available in M3x0.6 internal thread.
GD series and PD series(except for PD4D) are used to remove calculus deposits from teeth; PD4D and ED1 are used for root canal indication.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth, root canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professionals
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing: The biocompatibility evaluation for the Ultrasonic Scaler Tips was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management Section 5_510(k) Summary process". The biocompatibility testing included the following tests:
- Cytoxicity
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity
- Material-mediated Pyrogens
Reprocessing Validation: Sterilization has been validated in conformance to the FDA recognized consensus standard ISO 17665-1:2006 Sterilization of health care products - moist heat - Part 1: requirements for the development, validation and routine control of a sterilization process for medical devices. Cleaning validation testing is performed in accordance with recommended evaluations as listed in AAMI TIR30, AAMI TIR12, and Guidance for Industry and FDA Staff - Processing Medical Devices in Health Care Settings.
Bench Performance Testing: Testing was conducted to demonstrate conformity to the applicable clauses of the following standards:
- . ISO 18397 Dentistry Powered scaler
- ISO 3630-5 Dentistry Endodontic instruments Part 5: Shaping and cleaning instruments
Clinical data: The subject of this premarket submission, ultrasonic scaler tips, did not require clinical studies to support substantial equivalence.
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
November 21, 2023
Guilin Refine Medical Instrument Co., Ltd. % Alice Yang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 CHINA
Re: K230641
Trade/Device Name: Ultrasonic Scaler Tips Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: August 28, 2023 Received: August 28, 2023
Dear Alice Yang:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230641
Device Name
Ultrasonic Scaler Tips
Indications for Use (Describe)
- The ultrasonic scaler tips are intended for use by dental professionals to:
-
- Remove supra and sub gingival calculus deposits and stain from the teeth;
-
- Clean and irrigate root canals.
Type of Use (Select one or both, as applicable) | |
---|---|
Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(K) Summary K230641
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: November 20, 2023
Submission sponsor 1.
Name: Guilin Refine Medical Instrument Co., Ltd.
Address: No.8-3, Information Industrial Park, High-Tech Zone, Qixing District, Guilin, GuangXi, China 541004
Contact person: Chen Judong
Title: Management Representative
E-mail: chenjudong@refine-med.com
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067
Contact person: Alice Yang
E-mail: yangjie@chonconn.com
Tel: +86-755 33941160
Trade/Device Name | Ultrasonic Scaler Tips |
---|---|
Model | GD1, GD2, GD4, GD5, GD6, PD1, PD3, PD4, PD4D, ED1 |
Regulatory Class | Class II |
Classification | 21 CFR 872.4850 / Ultrasonic scaler / ELC |
Submission type | Traditional 510(K) |
3. Subiect Device Information
4. Predicate Device
-
- Sapphire Plus@ Tips, San Diego Swiss Machining, K960889 (Primary)
-
- tün® ultrasonic tips product family, Engineered Endodontics., K182145 (Reference)
Symmetry S-Series Piezoelectric Scaling Tips, Hu-Friedy Manufacturing Company, Incorporated, 3. K053178 (Reference).
5. Device Description
Ultrasonic scaler tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. The devices are used during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodontic applications to prepare the teeth and/or root of the teeth for repair.
The models are GD1, GD2, GD4, GD5, GD6, PD1, PD3, PD4, PD4D, ED1. The Ultrasonic scaler tips are
Section 5_510(k) Summary
5
made from Stainless Steel 30Cr13 and the endo files are made of Nickel Titanium Alloy. The tips will beavailable in M3x0.6 internal thread .
GD series and PD series(except for PD4D) are used to remove calculus deposits from teeth; PD4D and ED1 are used for root canal indication.
Intended use & Indication for use 6.
The ultrasonic scaler tips are intended for use by dental professionals to:
-
- Remove supra and sub gingival calculus deposits and stain from the teeth;
-
- Clean and irrigate root canals.
| Features | Proposed device
Ultrasonic
Scaler Tip | Primary
Predicate
device K960889
Sapphire
Plus@ Tips | Reference
Predicate
device
K053178
Symmetry S-
Series
Piezoelectric
Scaling Tips | Reference
Predicate device
K182145
tün® ultrasonic
tips Product
Family | comment |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product code | ELC | ELC | ELC | ELC | Same |
| Regulation
number | 21 CFR 872.4850 | 21 CFR
872.4850 | 21 CFR
872.4850 | 21 CFR
872.4850 | Same |
| Regulation
Class | Class II | Class II | Class II | Class II | Same |
| Regulation
Description | Scaler, Ultrasonic | Scaler,
Ultrasonic | Scaler,
Ultrasonic | Scaler,
Ultrasonic | Same |
| Intended Use | The ultrasonic
scaler tips are
intended for use
by dental
professionals to:
- Remove supra
and sub gingival
calculus deposits
and stain from the
teeth; | Reconstructive
dental tissue
during endo root
procedures,
crown prep,
canal prep.
Remove perio
prep, root prep | To be used by
Dental
Professionals
during dental
cleaning and
periodontal
(gum)
therapy to
remove
calculus,
plaque and
staining of the
teeth by | 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 | SE |
| Features | Proposed device | Primary
Predicate
device K960889
Sapphire
Plus@ Tips | Reference
Predicate
device
K053178
Symmetry S-
Series
Piezoelectric
Scaling Tips | Reference
Predicate device
K182145
tün® ultrasonic
tips Product
Family | comment |
| | 2. Clean and
irrigate root
canals. | | application of
an
ultrasonic
vibrating tip
to the teeth. | and other intra-
canal blockages. | |
| Device
Description | The device is
used during
dental cleaning
and
periodontal(gum)
therapy to remove
calculus deposits
from teeth by
application of
ultrasonic
vibration and in
various
endodontic
applications to
prepare the teeth
and /or root of the
teeth for repair. | The device is
used during
dental cleaning
and
periodontal(gum
) therapy to
remove calculus
deposits from
teeth by
application of
ultrasonic
vibration and in
various
endodontic
applications to
prepare the
tooth and /or
root of the tooth
for repair. | This device is
intended to be
used by dental
professionals
for dental
cleaning and
periodontal
therapy to
remove
calculus from
the teeth | 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. | SE |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| Operating
Principle | The tips are used
on piezo
ultrasonic
endodontic and
scaler units which
operate in the
range of 23kHz- | Used in
conjunction
with
piezoelectric
ultrasonic
handpiece and
scaler. | Compatible
with 27-32
kHz generator | tün tips interact
with piezo
ultrasonic hand
piece and unit.
tün tips are an
accessory to a
piezo ultrasonic | Different |
| | | | | | |
| | | | | | |
| Features | Proposed device
Ultrasonic
Scaler Tip | Primary
Predicate
device K960889
Sapphire
Plus@ Tips | Reference
Predicate
device
K053178
Symmetry S-
Series
Piezoelectric
Scaling Tips | Reference
Predicate device
K182145
tün® ultrasonic
tips Product
Family | comment |
| | 33kHz. | Ultrasonic
energy vibrates
tip at high
frequencies (up
to 40,000 Hz) | | 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. | |
| Tip
Shapes/Types | GD series and PD
series(except for
PD4D) are used
to remove
calculus deposits
from teeth; PD4D
and ED1 are used
for root canal
indication. | Four different
types of tips will
be manufactured
as follows:
Scaler tips,
Plugger Tips,
Cutting Tips,
Spreader Tips | | 1 tip design is
devised for post
removal; the
remaining 5 tips
are designed for
negotiating the
various angles
and directions of
root canals. | Different |
| Composition | Stainless Steel
30Cr13
Nickel Titanium
Alloy(endo files) | 13-8 stainless
steel | | 17-4ph Stainless
Steel | Different |
| Coatings | None | Titanium Nitride
Zirconium
Nitride | | Nickel Plating or
Diamond Nickel
Plating | Different |
| Interaction
with other
products
and/or items
used with the
product | brands of Piezo-
Electric type
dental ultrasonic
Scalers that use
an M3x0.6 thread | | | brands of Piezo-
Electric type
dental ultrasonic
Scalers that use
an M3x0.5 or
M3x0.6 thread | Same |
| Features | Proposed device
Ultrasonic
Scaler Tip | Primary
Predicate
device K960889
Sapphire
Plus@ Tips | Reference
Predicate
device
K053178
Symmetry S-
Series
Piezoelectric
Scaling Tips | Reference
Predicate device
K182145
tün® ultrasonic
tips Product
Family | comment |
| Sterilization | Provided non- | Provided non- | Provided non- | Provided non- | Same |
| Status | sterile. | sterile. | sterile. | sterile. | |
| Sterilization
method | steam
sterilization
Sterilization
requirements: 4
minutes at
132 °C a
drying time of
minimum 20
minutes | Yes, no detail
information | Steam sterilize
for at least 4
minutes at
270 °F /
132 °C or 30
minutes at
250 °F /
121 °C. Do
not heat above
275 °F /
135 °C
Recommend
at least 30
minute dry
time after
sterilization
cycle | Gravity Steam
Sterilizer:
• Temperature:
250°F /121°C.
• Cycle Time: 30
minutes
• Maximum Dry
Time: 30 minutes
Prevacuum
Steam Sterilizer:
• Temperature:
270°F/132°C.
• Cycle Time: 4
minutes
• Maximum
Dry Time: 30
minutes | Different |
| Mechanism
of treatment | Application of an
ultrasonic
vibrating scaler
tip to the teeth | Application of
an ultrasonic
vibrating scaler
tip to the teeth | Application of
an ultrasonic
vibrating
scaler tip to
the teeth | Application of an
ultrasonic
vibrating scaler
tip to the teeth | Same |
Comparison to the Predicate Device 7.
6
Section 5_510(k) Summary
7
Section 5_510(k) Summary
8
Performance Data 8.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Ultrasonic Scaler Tips was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management Section 5_510(k) Summary
9
process". The biocompatibility testing included the following tests:
- Cytoxicity
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity
- Material-mediated Pyrogens
Reprocessing Validation
Sterilization has been validated in conformance to the FDA recognized consensus standard ISO 17665-1:2006 Sterilization of health care products - moist heat - Part 1: requirements for the development, validation and routine control of a sterilization process for medical devices. Cleaning validation testing is performed in accordance with recommended evaluations as listed in AAMI TIR30, AAMI TIR12, and Guidance for Industry and FDA Staff - Processing Medical Devices in Health Care Settings.
Bench Performance Testing
Testing was conducted to demonstrate conformity to the applicable clauses of the following standards:
- . ISO 18397 Dentistry Powered scaler
- ISO 3630-5 Dentistry Endodontic instruments Part 5: Shaping and cleaning instruments
Clinical data
The subject of this premarket submission, ultrasonic scaler tips, did not require clinical studies to support substantial equivalence.
9. Conclusion
Based on the similarities in intended use, principles of operation, design rationale, test results, and performance, the subject ultrasonic scaler tips are considered to be substantially equivalent to the predicate devices.