Smartcord, Smartcord X

K171577 · Eastdent Co., Ltd. · MVL · May 3, 2018 · DE

Device Facts

• Record ID: K171577
• Device Name: Smartcord, Smartcord X
• Applicant: Eastdent Co., Ltd.
• Product Code: MVL · DE
• Decision Date: May 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Smartcord is knitted retraction cord made from 100% cotton for the temporary gingival retraction. Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate for the temporary gingival retraction and hemostasis of the gingival margin.

Device Story

Smartcord and Smartcord X are knitted cotton retraction cords used by dental professionals for temporary gingival retraction during dental procedures. Smartcord X is impregnated with Aluminum Chloride Hexahydrate to provide additional hemostasis of the gingival margin. The cords are placed into the gingival sulcus to displace tissue, facilitating accurate dental impressions or cavity preparation. The device is non-sterile and intended for short-term contact (less than 24 hours). The clinician selects the appropriate cord thickness based on the patient's gingival anatomy and uses color-coding to distinguish between different diameters and ensure contrast against oral tissues. The device provides a mechanical means to manage gingival tissue and a chemical means (in the case of Smartcord X) to control minor bleeding, aiding the dentist in achieving clear margins for restorative work.

Clinical Evidence

Bench testing only. Biocompatibility testing was conducted in accordance with ISO 10993-1, including Cytotoxicity (ISO 10993-5), Oral Mucous Irritation (ISO 10993-10), and Sensitization (ISO 10993-10).

Technological Characteristics

Knitted retraction cord made of 100% cotton. Smartcord X is impregnated with Aluminum Chloride Hexahydrate (1.2mg ± 0.8mg/inch). Available in various thicknesses and colors for identification. Non-sterile. Biocompatible per ISO 10993-1. Storage: 1-35°C in dry, dark conditions.

Indications for Use

Indicated for temporary gingival retraction (Smartcord) and temporary gingival retraction and hemostasis of the gingival margin (Smartcord X) in dental patients.

Predicate Devices

• Knit Pak plus / Knit Pak ™ (K132526)

Submission Summary (Full Text)

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EASTDENT Co., Ltd Hyonsu Kim CEO 601-1 Sogong B/D. 64 Gugal-ro. Giheung-gu Yongin-si, 16972 Korea

Re: K171577

Trade/Device Name: Smartcord, Smartcord X Regulatory Class: Unclassified Product Code: MVL Dated: March 26, 2018 Received: April 3, 2018

Dear Hyonsu Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

May 3, 2018

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### Page 2 - Hyonsu Kim

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mary S. Runner -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K171577

Device Name Smartcord, Smartcord X

Indications for Use (Describe)

Smartcord is knitted retraction cord made from 100% cotton for the temporary gingival retraction.

Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride for the temporary gingival retraction and hemostasis of the gingival margin.

| <span> <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 12px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|

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Type of Use (Select one or both, as applicable)

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# K171577

# 510(K) SUMMARY

# Smartcord, Smartcord X

#### Date: ___ March 26, 2018

### I. SUBMITTER

EASTDENT CO., LTD. 601-1, 64, Gugalro, Giheung-gu, Yongin-si, Gyeonggi-do, 16972, Korea

Tel: [phone] Fax: [phone]

Contact Name: Hyonsu, Kim Email: [e-mail]

#### II. DEVICE

| Name of Device: | Smartcord, Smartcord X |
|----------------------|------------------------|
| Regulation Name: | Retraction Cord |
| Classification Name: | Cord, Retraction |
| Regulatory Class: | Unclassified |
| Product Code: | MVL |

#### III. PREDICATE DEVICE

K132526, Knit Pak plus / Knit Pak ™, Premier dental company products, Inc.

### IV. DEVICE DESCRIPTION

Smartcord is non-impregnated knitted retraction cord made from 100% cotton. Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate.

#### V. INDICATIONS FOR USE

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Smartcord is knitted retraction cord made from 100% cotton for the temporary gingival retraction.

Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate for the temporary gingival retraction and hemostasis of the gingival margin.

# VI. COMPARISON OF TECHNILOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Smartcord

| | Subject Device | Predicate Device | Summary |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Smartcord | Knit-Pak™ | - |
| Manufacturer | EASTDENT CO., LTD. | Premier Dental Company<br>Products | - |
| 510(k) Number | New | K132526 | - |
| Classification<br>Name | Retraction Cord | Retraction Cord | Same |
| Product Code | MVL | MVL | Same |
| Device Class | Unclassified | Unclassified | Same |
| Intended user | Dental professional | Dental professional | Same |
| Description | Smartcord is non-impregnated knitted<br>retraction cord made from<br>100% cotton. | Knit-Pak™ Gingival<br>retraction cord is non-impregnated knitted cord<br>made from 100% cotton. | Same |
| Indications for<br>Use | Smartcord is knitted<br>retraction cord made from<br>100% cotton for the<br>temporary gingival<br>retraction. | Not Listed | - |
| Raw material | Yarn : cotton<br>Coloring agent | Yarn : cotton<br>Coloring agent | Same |
| Gingival<br>retraction cord<br>Type | Non-Impregnated | Non-Impregnated | Same |
| Recommended<br>contact time | 3 minutes | Not Listed | - |
| Color | · 03 : black/gray<br>· 02 : brown/yellow<br>· 0 : purple/light purple<br>· 1 : blue/light blue<br>· 2 : green/light green | · 000 : Green<br>· 00 : Brown<br>· 0 : Purple<br>· 1 : Blue<br>· 2 : Orange | Different. But the<br>retraction cords are<br>available in various colors<br>to be a dark to maximize |
| | | 3 : Yellow | contrast with the tissues, tooth, and cord. |
| Thickness | · 03<br>· 02<br>· 0<br>· 1<br>· 2 | · 000<br>· 00<br>· 0<br>· 1<br>· 2<br>· 3 | Different. But the retraction cords are available in various diameters(thickness) to accommodate variations in gingival anatomy. |
| Length | 305 cm / 120 inches | 254 cm / 100 inches | Different |
| Biocompatibility | Device is biocompatible when used as directed by dental professionals per ISO 10993-1. | Device is biocompatible when used as directed by dental professionals per ISO 10993-1. | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Storage condition | Store in a dry, dark place between 1 and 35°C | Not Listed | - |
| Shelf Life | N/A | N/A | Same |

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# Smartcord X

| | Subject Device | Predicate Device | Summary |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Smartcord X | Knit-Pak+ | - |
| Manufacturer | EASTDENT CO., LTD. | Premier Dental Company<br>Products | - |
| 510(k) Number | New | K132526 | - |
| Classification<br>Name | Retraction Cord | Retraction Cord | Same |
| Product Code | MVL | MVL | Same |
| Device Class | Unclassified | Unclassified | Same |
| Intended user | Dental professional | Dental professional | Same |
| Description | Smartcord X is knitted<br>retraction cord made from<br>100% cotton, impregnated<br>with Aluminum Chloride<br>Hexahydrate. | Not Listed | - |
| Indications for<br>Use | Smartcord X is knitted<br>retraction cord made from<br>100% cotton, impregnated<br>with Aluminum Chloride | Knit-Pak+ impregnated<br>consists of a specialized<br>design of knitted<br>polyamide/polyester | Same |
| | Hexahydrate for the<br>temporary gingival<br>retraction and hemostasis<br>of the gingival margin. | conjugated cord. This<br>retraction cord is<br>impregnated with<br>Aluminum<br>ChlorideHexahydrate and<br>is intended for accurate<br>and enhanced results<br>when acquiring dental<br>impressions, for cavity<br>preparation or wherever<br>hemostasis and retraction<br>is required. | |
| Contents | Aluminum chloride<br>hexahydrate(1.2mg±0.8m<br>g/inch) | AlCl36H2O(0.5mg±0.1mg/<br>inch) | Different. But the products<br>consisting up to 15%<br>Aluminum Chloride<br>(Aluminum Chloride<br>Hexahydrate) fall under<br>the OTC monograph<br>accepted by the FDA. |
| Raw material | Yarn : cotton<br>Hemostatic agent :<br>Aluminum chloride<br>hexahydrate<br>Coloring agent | Yarn : polyamide/polyester<br>Hemostatic agent :<br>Aluminum chloride<br>hexahydrate<br>Coloring agent | Different. Yarns are<br>different, but hemostatic<br>agent (Aluminum chloride<br>hexahydrate) is the same. |
| Gingival<br>retraction cord<br>Type | Impregnated | Impregnated | Same |
| Body contact | Gingival sulcus | Gingival sulcus | Same |
| Recommended<br>contact time | 3 minutes | Not Listed | - |
| Color | · 03 : black/gray<br>· 02 : brown/yellow<br>· 0 : purple/light purple<br>· 1 : blue/light blue<br>· 2 : green/light green | · 000.0 : Dark Green<br>· 000 : Green<br>· 00 : Brown<br>· 0 : Purple<br>· 1 : Blue<br>· 2 : Orange | Different. But the<br>retraction cords are<br>available in various colors<br>to be a dark to maximize<br>contrast with the tissues,<br>tooth, and cord. |
| Thickness | · 03<br>· 02<br>· 0<br>· 1<br>· 2 | · 000.0<br>· 000<br>· 00<br>· 0<br>· 1<br>· 2 | Different. Retraction cords<br>are available in various<br>diameters (thickness) to<br>accommodate variations<br>in gingival anatomy. |
| Length | 254cm / 100 inches | 254 cm / 100 inches | Same |
| Biocompatibility | Device is biocompatible<br>when used as directed by<br>dental professionals per<br>ISO 10993-1. | Device is biocompatible<br>when used as directed by<br>dental professionals per<br>ISO 10993-1. | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Storage<br>condition | Store in a dry, dark place<br>between 1 and 35°C | Not Listed | |
| Shelf Life | 3 years | 3 years | Same |

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#### VII. NON-CLINICAL PERFORMANCE TESTING

The biocompatibility evaluation for the Smartcord X device was conducted in accordance with the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff, issued on: June 16, 2016, and international Standard ISO 10993-1 "Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process" as recognized by FDA. The tests carried out for the devices and standards applied for each test are:

- . Cytotoxicity, ISO 10993-5[2009]
- . Oral mucous Irritation, ISO 10993-10[2010]
- ・ Sensitization, ISO 10993-10[2010]

Smartcord X is considered to be in contact with gingival sulcus for duration of less than 24 hours, while being the external communicating device.

#### VIII.SUBSTANTIAL EQUIVALENCE DISCUSSION

The subject device consists of gingival retraction non-impregnated or impregnated cord, as is the predicate device. The subject device is same to predicate device in terms of classification name, product code, device class, indication for use, intended user, contents, raw materials, gingival retraction cord type, body contact, biocompatibility, sterilization, storage condition and shelf life.

There are no new ingredients or technology used on subject device. Their physical properties and performance of subject device are not significantly different from the predicate device, as indicated by non-clinical performance testing. The colors and thickness are different between subject device and predicate device. Differences of thickness and colors exist between the subject device and the predicate device.

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However, these differences of colors and thickness do not influence(affect) its intended use for performance. Dentist select the thickness of retraction cord by the type and form of gingiva. The purpose of color use is only to distinguish the retraction cords from the gingiva, and the various colors is used for identification of the thickness to accommodate variations in gingival types and forms.

### IX. CONCLUSIONS

The indications and technological characteristics of Smartcord X are very similar to predicate device. Therefore, Subject devices are substantially equivalent to the identified predicate device.