(407 days)
Not Found
No
The summary describes a mechanical dental handpiece and does not mention any AI or ML capabilities.
Yes
The device is used for a wide range of dental procedures including implant placement, periodontal surgeries, bone grafting, and removal/sectioning of teeth, all of which are considered therapeutic interventions aimed at treating a condition or disease.
No
The device description and intended use indicate it is an instrument for performing dental procedures (e.g., preparing osteotomies, bone contouring, tooth removal), not for diagnosing conditions.
No
The device description explicitly states it is a "gear driven hand-held dental handpiece" and describes physical components and mechanisms, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for various dental procedures performed directly on the patient (implant placement, periodontal surgeries, bone grafting, tooth removal). IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The description details a mechanical dental handpiece used for preparing cavities and cleaning teeth, which are direct patient treatments, not laboratory tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
The device is a surgical dental instrument used for direct treatment of the patient.
N/A
Intended Use / Indications for Use
The TRAUS Dental Handpieces, TRAUS CRB46LN and TRAUS CRB46NN are intended for a wide range of dental procedures including:
A. Implant placement , including
-
- Preparation of the osteotomy site
-
- Bone contouring , osteoplasty
B. Periodontal surgeries
- Bone contouring , osteoplasty
-
- Bone contouring & alveoplasty around living teeth
-
- Removal of exostosis
C. Bone grafting
- Removal of exostosis
-
- Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
-
- Harvesting autogen living bone
-
- Sinus elevation & grafting of alveolar sockets
D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions
Product codes (comma separated list FDA assigned to the subject device)
EGS
Device Description
The TRAUS Dental Handpieces; TRAUS CRB46LN and TRAUS CRB46NN are gear driven hand-held dental handpieces with Gear Ratio of 20:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility
Patient contact materials of the TRAUS Dental Handpieces are as follows:
- TRAUS CRB46LN, TRAUS CRB46NN
| Part | Material | Surface treatment | Patient contact | Duration of Contact by ISO 10993-1 | Biocompatibility |
|---|---|---|---|---|---|
| Head and nozzle | SUS303F | Hard Chrome Coated | Yes | Limited ( |
§ 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
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 26, 2019
Saeshin Precision Co., Ltd. Choi Jong Woo Quality Manager 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, 42921 Republic of Korea
Re: K182892
Trade/Device Name: TRAUS Dental Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EGS Dated: August 21, 2019 Received: September 3, 2019
Dear Choi Jong Woo:
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.
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
1
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 (OS) 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 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).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices 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) K182892
Device Name TRAUS Dental Handpieces
Indications for Use (Describe)
The TRAUS Dental Handpieces, TRAUS CRB46LN and TRAUS CRB46NN are intended for a wide range of dental procedures including:
A. Implant placement , including
-
- Preparation of the osteotomy site
-
- Bone contouring , osteoplasty
- B. Periodontal surgeries
-
- Bone contouring & alveoplasty around living teeth
-
- Removal of exostosis
- C. Bone grafting
-
- Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
-
- Harvesting autogen living bone
-
- Sinus elevation & grafting of alveolar sockets
D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions
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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3
Image /page/3/Picture/0 description: The image shows the logo for SAESHIN. The logo features a blue geometric shape above the company name, which is also in blue. Below the logo is the company's address, which includes "echeon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu".
52, Secheon-ro 1-gil, Dasa-eup, Dalseong-Tel: +82 53 587 2345 / Fax: +82 53 580 0939
510(k) Summary
[As required by 21 CFR 807.92]
1. 510(k) Number
2. Date Prepared [21 CFR 807.92(a)(1)]
November 20, 2019
3. Submitter's Information [21 CFR807.92(a)(1)]
- . Name of Applicant: Saeshin Precision Co., Ltd.
-
52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Address: -Daegu, 42921, Republic of Korea
-
- Contact Name: Jong Woo, Choi (Mr.) / Quality Manager .
- Telephone No. : +82 53 587 2345 -
- -Fax No. : +82 53 580 0939
- Email Address : ksqc@saeshin.com -
- . Registration Number: 3007958831
4. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| • | Trade Name: | TRAUS Dental Handpieces |
|---|---|---|
| • | Classification Name: | Dental Handpieces and Accessories |
| • | Common Name: | Handpiece, Contra- And Right-Angle Attachment, |
| Dental | ||
| • | Classification Panel: | Dental |
| • | Classification Regulation: | 21 CFR 872.4200 |
| • | Product Code: | EGS |
| • | Device Class: | I |
4
Image /page/4/Picture/0 description: The image shows the logo and contact information for a company called SAESHIN. The logo is a blue geometric shape. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is +82 53 587 2345 and the fax number is +82 53 580 0939.
5. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follows:
- 510(k) Number: K171436 ●
- Applicant: Saeshin Precision Co., Ltd. .
- Common Name: . Dental Handpieces and Accessories
- Device Name: STRONG Dental Handpieces
There are no significant differences between the Model TRAUS Dental Handpieces and the predicate device. It is substantially equivalent to these devices in device design, composition of materials and technical specifications.
6. Description of the Device [21 CFR 807.92(a)(4)]
The TRAUS Dental Handpieces; TRAUS CRB46LN and TRAUS CRB46NN are gear driven hand-held dental handpieces with Gear Ratio of 20:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
7. Indications for Use [21 CFR 807.92(a)(5)]
The TRAUS Dental Handpieces, TRAUS CRB46LN and TRAUS CRB46NN are intended for a wide range of dental procedures including:
- A. Implant placement, including
-
- Preparation of the osteotomy site
-
- Bone contouring, osteoplasty
-
- B. Periodontal surgeries
-
- Bone contouring & alveoplasty around living teeth
-
- Removal of exostosis
-
- C. Bone grafting
-
- Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
-
- Harvesting autogen living bone
-
- Sinus elevation & grafting of alveolar sockets
-
- D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions
5
Image /page/5/Picture/0 description: The image shows the logo for SAESHIN. The logo consists of a blue geometric shape above the word "SAESHIN" in a stylized blue font. The geometric shape is made up of several smaller shapes, creating a three-dimensional effect. The overall design is modern and corporate.
8. Technological Characteristics [21 CFR 807.92(a)(6)]
| TRAUS CRB46LN | TRAUS CRB46NN | ||
|---|---|---|---|
| Revolu- | |||
| tion | Max Speed | ||
| in Rpm | 40,000 rpm | 40,000 rpm | |
| After the gear | |||
| speed reduction | 2,000 rpm | 2,000 rpm | |
| Gear Ratio | 20:1 | 20:1 | |
| Weight | approx.87g | approx.88g | |
| Size | Ø20 x 94.8mm | Ø20 x 94.8mm | |
| Articles | Low speed angle | Low speed angle | |
| Standard Coupling | ISO 3964 | ISO 3964 |
6
Image /page/6/Picture/0 description: The image shows the logo and contact information for a company called SAESHIN. The logo is a blue geometric shape. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is +82 53 587 2345 and the fax number is +82 53 580 0939.
Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] 9.
When compared to the predicate device (K171436), the STRONG Dental Handpieces presented in this submission has the same:
- Indications for Use .
- Device Design .
- Composition of materials .
- · Technical Specifications
| Parameter | Proposed
TRAUS Dental Handpieces (Model Nos.:
TRAUS CRB46LN, TRAUS CRB46NN) | Predicate
STRONG Dental Handpieces (Model Nos.:
ACL(B)-611, ACL(B)-621, ACL(B)-631,
ACL(B)-651, ACL(B)-04C) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Unknown | K171436 |
| Manufacturer | Saeshin Precision Co., Ltd | Saeshin Precision Co., Ltd. |
| Indications for Use | The TRAUS Dental Handpieces are indicated for wide range of dental procedures.
A. Implant placement, including
- Preparation of the osteotomy site
- Bone contouring, osteoplasty
B. Periodontal surgeries - Bone contouring & alveoplasty around living teeth
- Removal of exostosis
C. Bone grafting - Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
- Harvesting autogen living bone
- Sinus elevation & grafting of alveolar sockets | The Strong Dental Handpieces are indicated for wide range of dental procedures.
A. Implant placement, including - Preparation of the osteotomy site
- Bone contouring, osteoplasty
B. Periodontal surgeries - Bone contouring & alveoplasty around living teeth
- Removal of exostosis
C. Bone grafting - Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
- Harvesting autogen living bone
- Sinus elevation & grafting of alveolar sockets
D. Removal and sectioning of teeth and teeth |
| Parameter | Proposed
TRAUS Dental Handpieces (Model Nos.:
TRAUS CRB46LN, TRAUS CRB46NN) | Predicate
STRONG Dental Handpieces (Model Nos.:
ACL(B)-61I, ACL(B)-62I, ACL(B)-631,
ACL(B)-651, ACL(B)-04C) |
| | D. Removal and sectioning of teeth and teeth
bone for e.g. impacted third molars and
complicated extractions | bone for e.g. impacted third molars and
complicated extractions |
| Device Design | | |
| Operational Mode | Gear | Gear |
| Gear Ratio | 20:1 | 20:1, 16:1, 64:1, 32:1, 1:1 |
| Length | 94.8 mm | 96.9, 96.9, 99.5, 96.9, 83.3 mm |
| Diameter | Ø 20 | Ø 19.6 |
| Dia. of tool | 2.35 mm | 2.35 mm |
| Max. Overall Length of
Rotary Instrument | 30 mm | 30 mm |
| Head Height | 14 mm | 14.45,14.2 mm |
| Head Diameter | Ø 9.6 mm | Ø 8, Ø 7.7 mm |
| Shank | By ISO 1797-1 | By ISO 1797-1 |
| Length of Shank | 9 – 12 mm | 9 – 12 mm |
| Type of Chuck | Push-Button Locking | Push-Button Locking |
| Coupling Dimension | By ISO 3964 | By ISO 3964 |
| Type of Connector | Not Applied | Not Applied |
| Accessories | Spray Nozzle | Spanner |
| Composition of Materials
/Surface treatment | | |
| Gear | SUS420F/Vacuum Heat Treatment | SUS420F/Vacuum Heat Treatment |
| Shank | N/A | SUS304 |
| Head and Nozzle | SUS303F/Hard Chrome coated | SUS303F/Hard Chrome coated |
| Chuck | SUS420F/Vacuum Heat Treatment | SUS420F/Vacuum Heat Treatment |
| Handle | SUS303F/Hard Chrome coated | AL6061/Anodizing |
| Pipe | SUS304/Hard Chrome coated | SUS303F/Hard Chrome coated |
| | | N/A (ACL(B)-04C) |
| Patient-Contacting | Chuck, Head | Chuck, Head |
| Operator-Contacting | Handle, Head | Handle, Head |
| Technical Specification | | |
| Chuck Design | Type1 Push-Button Locking by ISO 1797-1 | Type1 Push-Button Locking by ISO 1797-1 |
| Parameter | Proposed
TRAUS Dental Handpieces (Model Nos.:
TRAUS CRB46LN, TRAUS CRB46NN) | Predicate
STRONG Dental Handpieces (Model Nos.:
ACL(B)-61I, ACL(B)-62I, ACL(B)-631,
ACL(B)-65I, ACL(B)-04C) |
| Bur Extraction Force(N)
Max. Torques
Max. Water Pressure
Max. Speed in rpm
Shank Conformance
Coupling Dimension
Lubricant
Chemical Composition
Biocompatible
Delivery system | 45 N
80 Ncm
N/A
40,000 rpm
By ISO 1797-1
By ISO 3964
N/A
510k# | 45 N
50 Ncm
N/A
50,000 rpm, 35,000 rpm
By ISO 1797-1
By ISO 3964
N/A |
| Sterilization | Steam Heat 132 °C / 4minutes | Steam Heat 132 °C / 4minutes |
| Operating principle | The TRAUS Dental Handpieces are gear driven
hand-held dental handpieces with gear ratio of
20:1. It can be driven by torque adjustable
electrical motors for surgery treatment. It is
attached to drive via ISO 3964 coupling. The
head clamp accepts instrument complying with
ISO 1797-1. They have contra angle attachment
for difficult to reach areas intended to prepare
dental cavities for restorations, such as fillings,
and for cleaning teeth. | The STRONG Dental Handpieces are gear
driven hand-held dental handpieces with gear
ratio of 20:1, 16:1, 64:1, 32:1 and 1:1. It can be
driven by torque adjustable electrical motors
for surgery treatment. It is attached to drive via
ISO 3964 coupling. The head clamp accepts
instrument complying with ISO 1797-1. They
have contra angle attachment for difficult to
reach areas intended to prepare dental cavities
for restorations, such as fillings, and for
cleaning teeth. |
7
Image /page/7/Picture/0 description: The image shows the logo for SAESHIN. The logo consists of a geometric shape made up of blue triangles above the company name, which is also in blue. Below the company name is the text "Dasa-eup, Dalseong-gun, Daegu".
8
Image /page/8/Picture/0 description: The image shows the logo for SAESHIN, which is written in a stylized blue font. Above the company name is a geometric blue logo. Below the logo is the address: # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu.
23921, Korea
Tel: +82 53 587 2345 / Fax: +82 53 580 0939
9
Image /page/9/Picture/0 description: The image shows the contact information for a company called SAESHIN. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is +82 53 587 2345, and the fax number is +82 53 580 0939.
10. Summary of Non-Clinical Performance Data
Biocompatibility
Patient contact materials of the TRAUS Dental Handpieces are as follows:
1) TRAUS CRB46LN, TRAUS CRB46NN
| Part | Material | Surface
treatment | Patient
contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|--------------------|----------|--------------------------|--------------------|---------------------------------------|-----------------------|
| Head and
nozzle | SUS303F | Hard Chrome
Coated | Yes | Limited (