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K Number
K152180
Device Name
PEAK
Manufacturer
Neosil Co., Ltd
Date Cleared
2015-10-22

(79 days)

Product Code
ELW
Regulation Number
872.3660
Type
Traditional
Panel
Dental
Reference & Predicate Devices
K102836
Predicate For
K180565
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

NS033C is to be used as a light body material for:

  • Two step putty/wash technique
  • · Single step putty/wash technique
  • · Functional peripheries
  • · Silicon dental impressions
  • Crown/bridge work
  • Inlays, Onlays

NS017C/NS017T is to be used as a heavy body material for:

  • Two step putty/wash technique
  • Single step putty/wash technique
  • · Functional peripheries
  • Crown/bridge work
  • Inlays, Onlays

MSP is to be used as a putty body material for:

  • Two step putty/wash technique
  • · Single step putty/wash technique
  • · Functional peripheries
  • Crown/bridge work
  • Inlays. Onlays

MSBC is to be used as a bite type for:

  • Making accurate occlusal registrations
  • · Standards bite registrations in the end bite position.
  • · Key material for needle point registration.
  • Production of small model segments

MSRC is to be used as a regular body material for:

  • Two step putty/wash technique
  • · Single step putty/wash technique
  • Functional peripheries
  • Reline impressions
  • Crown/bridge work
  • Inlays, Onlays

MSCC is to be used as a regular body material for:

  • Two step putty/wash technique
  • · Single step putty/wash technique
  • · Functional peripheries
  • · Reline impressions
  • Crown/bridge work
  • Inlays. Onlays
Device Description

PEAK is a two component (base paste and catalyst, mixing ratio 1:1) vinyl polysiloxane impression material to be used for impressions, where typically alginates are used. The PEAK offers four different viscosities (light, heavy, putty and regular) in delivery systems of cartridges and jars. The device includes accessories such as a spoon.

PEAK offers one light body type: NS033C.

PEAK offers two regular body types: MSRC and MSCC with different material compositions and color. The MSCC has clear appearance.

PEAK offers two heavy body types: NS017C/NS017T and MSBC with different material compositions and color. MSBC is a bite type particularly.

AI/ML Overview

This document describes the Neosil Co., Ltd. PEAK dental impression material and its substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, therefore, the requested information regarding acceptance criteria and study details for such a device is not present.

However, based on the provided text for the PEAK dental impression material, I can extract the acceptance criteria and performance data for this traditional medical device.

1. A table of acceptance criteria and the reported device performance:

The document compares the PEAK device to a predicate device (BONASIL A+ by DMP, Limited) based on physical properties, which serve as the acceptance criteria.

Acceptance Criteria (Predicate)Reported Device Performance (PEAK)
ISO 4823 SpecificationsMeets ISO 4823 specifications
Biocompatibility conforming to ISO 10993-1Biocompatible conforming to ISO 10993-1
Physical Properties
1) Bonasil A+ Light (Type 3):1) NS033C (Type 3):
- Working time: about 120sec- Working time: more than 40sec
- Elastic recovery rate: more than 96.5%- Elastic recovery rate: more than 96.5%
- Linear Dimensional change: less than 1.5%- Linear Dimensional change: less than 1.5%
2) Bonasil A+ Heavy (Type 1):2) NS017C/NS017T (Type 1):
- Working time: about 120sec- Working time: more than 40sec
- Elastic recovery rate: more than 96.5%- Elastic recovery rate: more than 96.5%
- Linear Dimensional change: less than 1.5%- Linear Dimensional change: less than 1.5%
3) Bonasil A+ Putty (Type 0):3) MSP (Type 0):
- Elastic recovery rate: more than 96.5%- Elastic recovery rate: more than 96.5%
- Linear Dimensional change: less than 1.5%- Linear Dimensional change: less than 1.5%
4) Bonasil A+Bonabite (Type 2):4) MSBC (Type 1): (Note: Classification Type differs for bite material, but other criteria are comparable.)
- Working time: about 30sec- Working time: more than 30sec
- Linear Dimensional change: less than 1.5%- Linear Dimensional change: less than 1.5%
- Hardness: more than 20HD(No direct comparable hardness criterion listed for MSBC, but it is a bite type material.) The document states "Classification according to the standards (ISO 4823) : Type 1" for MSBC, while Bonabite is Type 2. This difference in classification type is noted.
5) MSRC (Type 2):
(No direct predicate comparison for MSRC)- Mixing time: more than 30sec
- Elastic recovery rate: more than 96.5%
- Linear Dimensional change: less than 1.5%
6) MSCC (Type 2):
(No direct predicate comparison for MSCC)- Mixing time: more than 30sec
- Elastic recovery rate: more than 96.5%
- Linear Dimensional change: less than 1.5%

Note: For the MSRC and MSCC types, direct predicate comparisons for their specific physical properties are not listed in the table, but the conclusion states "All the test results support substantial equivalence to the predicate devices." indicating their performance met relevant criteria.

The study that proves the device meets the acceptance criteria is a series of non-clinical bench tests.

The requested information regarding AI/ML device studies is not applicable to this document. The document describes a traditional dental impression material, not an AI/ML powered device. Therefore, the following points cannot be answered:

  1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
  3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
  7. The sample size for the training set
  8. How the ground truth for the training set was established

Details available from the document regarding the study:

  • Type of Study: Non-Clinical Performance Testing and Biocompatibility Testing.
  • Tests Performed:
    • ISO 4823 (Consistency Test, Mixing Time Test, Working Time Test, Detail Reproduction Test, Test for Compatibility with Gypsum, Linear Dimensional Change Test, Elastic Recovery Test, and Strain-in-Compression Test)
    • ISO 10993-5 (Cytotoxicity Test)
    • ISO 10993-10 (Skin Sensitization Test, Oral Mucous Irritation Test)
    • ISO 10993-11 (Acute Systemic Toxicity Test)
    • Other bench testing (Shelf life, Visual Inspection, Weight and Component Color Check)
  • Conclusion: The manufacturer concluded that the PEAK device is substantially equivalent to the predicate devices based on these testing results.

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 22, 2015

Neosil Co., Ltd c/o Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group Usa, Inc. 2651 E Chapman Ave Ste 110 Fullerton, California 92831

Re: K152180

Trade/Device Name: PEAK Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 29, 2015 Received: August 4, 2015

Dear Ms. Chung:

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.

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152180

Device Name PEAK

Indications for Use (Describe)

NS033C is to be used as a light body material for:

  • Two step putty/wash technique
  • · Single step putty/wash technique
  • · Functional peripheries
  • · Silicon dental impressions
  • Crown/bridge work
  • Inlays, Onlays

NS017C/NS017T is to be used as a heavy body material for:

  • Two step putty/wash technique
  • Single step putty/wash technique
  • · Functional peripheries
  • Crown/bridge work
  • Inlays, Onlays

MSP is to be used as a putty body material for:

  • Two step putty/wash technique
  • · Single step putty/wash technique
  • · Functional peripheries
  • Crown/bridge work
  • Inlays. Onlays

MSBC is to be used as a bite type for:

  • Making accurate occlusal registrations
  • · Standards bite registrations in the end bite position.
  • · Key material for needle point registration.
  • Production of small model segments

MSRC is to be used as a regular body material for:

  • Two step putty/wash technique
  • · Single step putty/wash technique
  • Functional peripheries
  • Reline impressions
  • Crown/bridge work
  • Inlays, Onlays

MSCC is to be used as a regular body material for:

  • Two step putty/wash technique
  • · Single step putty/wash technique
  • · Functional peripheries
  • · Reline impressions
  • Crown/bridge work
  • Inlays. Onlays

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary (K152180)

This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.

October 21, 2015 Date: ________________________________________________________________________________________________________________________________________________________________________

Applicant / Submitter: 1.

Neosil Co., Ltd. 63, Gongdanseoro 18beon-gil, Geumjeong-gu, Busan Republic of Korea

Tel: +82-51-465-5456 Fax: +82-51-462-6810

2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831

Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device:

Proprietary Name:PEAK
Common Name:Dental Impression Material
Classification Name:Material, Impression
Classification:Class II, 21 CFR 872.3660
Classification Product Code:ELW

4. Predicate Device:

BONASIL A+ by DMP, Limited (K102836)

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Device Description: 5.

PEAK is a two component (base paste and catalyst, mixing ratio 1:1) vinyl polysiloxane impression material to be used for impressions, where typically alginates are used. The PEAK offers four different viscosities (light, heavy, putty and regular) in delivery systems of cartridges and jars. The device includes accessories such as a spoon.

PEAK offers one light body type: NS033C.

PEAK offers two regular body types: MSRC and MSCC with different material compositions and color. The MSCC has clear appearance.

PEAK offers two heavy body types: NS017C/NS017T and MSBC with different material compositions and color. MSBC is a bite type particularly.

6. Intended Use:

NS033C is to be used as a light body material for:

  • Two step putty/wash technique .
  • Single step putty/wash technique
  • Functional peripheries .
  • Silicon dental impressions
  • Crown/bridge work .
  • Inlays, Onlays

NS017C/NS017T is to be used as a heavy body material for:

  • Two step putty/wash technique .
  • Single step putty/wash technique .
  • · Functional peripheries
  • Crown/bridge work
  • · Inlays, Onlays

MSP is to be used as a putty body material for:

  • Two step putty/wash technique .
  • Single step putty/wash technique
  • Functional peripheries .
  • Crown/bridge work
  • Inlays, Onlays

MSBC is to be used as a bite type for:

  • · Making accurate occlusal registrations
  • · Standards bite registrations in the end bite position.
  • Key material for needle point registration. .
  • Production of small model segments

MSRC is to be used as a regular body material for:

  • Two step putty/wash technique .
  • Single step putty/wash technique .
  • · Functional peripheries
  • · Reline impressions
  • Crown/bridge work

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  • Inlays, Onlays .
    MSCC is to be used as a regular body material for:

  • Two step putty/wash technique

  • . Single step putty/wash technique

  • · Functional peripheries

  • · Reline impressions

  • Crown/bridge work

  • Inlays, Onlays

Performance Data(Non-Clinical): 7.

The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.

  • . ISO 4823 - Consistency Test, Mixing Time Test, Working Time Test, Detail Reproduction Test, Test for Compatibility with Gypsum, Linear Dimensional Change Test, Elastic Recovery Test, and Strain-in-Compression Test
  • ISO 10993-5 Cytotoxicity Test .
  • ISO 10993-10 Skin Sensitization Test, Oral Mucous Irritation Test .
  • . ISO 10993-11 - Acute Systemic Toxicity Test
  • . Other bench testing - Shelf life, Visual Inspection, Weight and Component Color Check

8. Substantial Equivalence

The PEAK is substantially equivalent to the predicate device described herein with respect to intended use, device design, accessory components, base material and delivery method. Also the curing mechanism of the subject device and the predicate devices is substantially equivalent in principle. This supports that the compatibility of the subject device are substantially equivalent to the predicate devices.

The difference might be the compositions of some materials; however, the biocompatibility and the results of performance testing performed according to ISO 4823 show that this difference does not raise issues in safety and effectiveness.

Subject DevicePredicate Device
510(K) NumberN / AK102836
Trade NamePEAKBONASIL A+
ManufacturerNeosil Co., LtdDMP, Limited
Product CodeELWELW
Intended UseNS033C is to be used as a light body material for:- Two step putty/wash techniqueBonasil A+ Light (light normal set, light fast set) is to be used as a light body material for :- Two step putty/wash technique
Single step putty/wash technique Functional peripheries Silicon dental impressions Crown/bridge work Inlays, Onlays NS017C/NS017T is to be used as a heavy body material for: Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work Inlays, Onlays MSP is to be used as a putty body material for: Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work Inlays, Onlays MSBC is to be used as a bite type for: Making accurate occlusal registrations Standards bite registrations in the end bite position. Key material for needle point registration. Production of small model segments MSRC is to be used as a regular body material for: Two step putty/wash technique Single step putty/wash technique Functional peripheries Reline impressions Crown/bridge work Inlays, Onlays MSCC is to be used as a regular body material for: Two step putty/wash technique Single step putty/wash technique Functional peripheries Reline impressions Crown/bridge work Inlays, OnlaysSingle step putty/wash technique Functional peripheries Reline impressions Crown/bridge work Inlays, Onlays Bonasil A+ Heavy (heavy normal set, heavy fast set) is to be used as a heavy body material for : Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work Inlays, Onlays Bonasil A+ Putty (putty normal set, putty fast set, putty soft, putty extra hard, lab putty) is to be used as a preliminary material for : Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work Inlays, Onlays Bonasil A+ Bonabite (bonabite fast set) is to be used as a light body material for: Making accurate occlusal registrations Standards bite registrations in the end bite position. Key material for needle point registration. Production of small model segments
Raw MaterialVinyl polysiloxaneVinyl polysiloxane
Human FactorReady to use dispensing systemReady to use dispensing system
BiocompatibilityBiocompatible conforming to ISO 10993-1Biocompatible conforming to ISO 10993-1
Meets ISO 4823 specificationsMeets ISO 4823 specifications
Physical Properties1) NS033C- Working time : more than 40sec- Elastic recovery rate : more than 96.5%- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO 4823) : Type 31) Bonasil A+ Light- Working time : about120sec- Elastic recovery rate : more than 96.5%- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO 4823) : Type 3
2) NS017C/NS017T- Working time : more than 40sec- Elastic recovery rate : more than 96.5%- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO 4823) : Type 12) Bonasil A+ Heavy- Working time : about 120sec- Elastic recovery rate : more than 96.5%- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO 4823) : Type 1
3) MSP- Elastic recovery rate : more than 96.5%- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO 4823) : Type 03) Bonasil A+ Putty- Elastic recovery rate : more than 96.5%- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO 4823) : Type 0
4) MSBC- Working time : more than 30sec- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO 4823) : Type 14) Bonasil A+Bonabite- Working time : about 30sec- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO 4823) : Type 2- Hardness : more than 20HD
5)MSRC- Mixing time : more than 30sec- Elastic recovery rate : more than 96.5%- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO 4823) : Type 2
6)MSCC- Mixing time : more than 30sec- Elastic recovery rate : more than 96.5%- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO 4823) : Type 2
Mixing ratio1:11:1
SterilityNon-sterileNon-sterile

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9. Conclusion:

Based on the testing results, Neosil Co., Ltd. concludes that the PEAK is substantially equivalent to the predicate devices.

§ 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).