DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY

• K Number: K103346
• Device Name: DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY
• Manufacturer: SHERPA KOREA
• Date Cleared: 2011-02-11 ( 88 days)
• Product Code: ELW
• Regulation Number: 872.3660

Intended Use

Delikit is an addition-cure vinyl polysiloxane dental that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

Device Description

Delikit is an addition-cure vinyl polysiloxane dental

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental impression material and contains no mention of AI or ML.

Therapeutic

No.
The device is described as an impression material for dental techniques, which is a diagnostic or procedural aid, not a device intended to treat or cure a disease or condition.

Diagnostic

No
The provided text describes Delikit as a "dental" material used for "impression techniques." There is no mention of it being used to identify, detect, or monitor a disease or condition, which are characteristics of a diagnostic device. It appears to be a material used for a procedure, not a diagnostic tool.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "vinyl polysiloxane dental" material, which is a physical substance used for impressions, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for taking dental impressions, which is a physical process for creating a mold of teeth and surrounding structures. This is a diagnostic procedure in the sense of gathering information, but it's not an in vitro (outside the body) test performed on biological samples to diagnose a condition.
• Device Description: The device is described as a dental material (vinyl polysiloxane) used for impressions. This aligns with a physical impression material, not a reagent or instrument used for analyzing biological samples.
• Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or performing tests in vitro.

Therefore, Delikit is a dental impression material used for diagnostic purposes in the context of dental procedures, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Delikit is an addition-cure vinyl polysiloxane dental that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

Product codes

ELW

Device Description

Not Found

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)

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.

Not Found

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

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines extending from its back, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MID 20993-0002

Sherpa Korea C/O Mr. Ramond Kelly Ray Kelly 56B Shadowbrook Drive Hudson, New Hampshire 03051

FEB 1 1 201

Re: K103346

Trade/Device Name: "Delikit" Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: August 30, 2010 Received: November 15, 2010

Dear Mr. Kelly:

.

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.

1

Page 2- Mr. Kelly

Enclosure

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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2

Image /page/2/Picture/0 description: The image shows a logo for Sherpa Korea. The logo consists of the word "Sherpa" in a bold, sans-serif font, with the word "Korea" in a smaller font below and to the right. Above the word "Sherpa" is a black square shape with a curved line underneath it, resembling a mountain or roof.

Sherpa Korea #611 e-space B/D Guro-3dong Guro-Gu, Seoul, Korea

Section 3

INDICATIONS FOR USE

103346

510(k) Number (if known):

Device Name:

Sherpa "Delikit" Impression Material

Indications For Use:

Delikit is an addition-cure vinyl polysiloxane dental that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runger

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K1103246