A dual-cure, composite resin core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown, is fabricated.

Device Description

A dual-cure, composite resin, core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown, is fabricated. It is substantially equivalent to many predicate materials that include self-, light-, and dual-cure types. This material incorporates fluoride-containing (trace amounts) glass filler particles. No Bisphenol-A or its precursors are used in the manufacturing process. The material is supplied in light-safe dual-barrel cartridges.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Parkell, Inc. Absolute Dentin II device:

Based on the provided 510(k) summary (K132115) for Absolute Dentin II, this document pertains to a dental material, specifically a composite resin core build-up material, and not an AI/ML-driven medical device. Therefore, many of the requested categories related to AI/ML device studies (like sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

The "acceptance criteria" for this type of device are primarily based on demonstrating substantial equivalence to predicate devices through biocompatibility testing and non-clinical performance testing of mechanical properties.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (as demonstrated by testing) and Reported Device Performance:

Since this is a material rather than a diagnostic or therapeutic AI device, "acceptance criteria" are typically defined by meeting established ISO standards for biocompatibility and demonstrating comparable physical properties to predicate devices. The document lists the tests conducted and states that all tests were passed.

Acceptance Criterion (Test Standard/Property)	Reported Device Performance (Absolute Dentin II)
Biocompatibility:
ISO 10993-5, 2009 (Cytotoxicity)	Passed (L929 MEM Elution Test)
ISO 10993-3, 2003 (Genotoxicity, Carcinogenicity, Reproductive Toxicity)	Passed (Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay)
ISO 10993-10, 2010 (Irritation and Skin Sensitization)	Passed (Intracutaneous Injection Test)
ISO 10993-10, 2010 (Irritation and Skin Sensitization)	Passed (Kligman Maximization Test)
ISO 10993-10, 2010 (Irritation and Skin Sensitization)	Passed (Oral Irritation Test - Acute Exposure)
Non-Clinical Performance Testing:	(Overall statement of compliance)
Flexural Strength	Tested (Implicitly met expectations for substantial equivalence)
Compressive Strength	Tested (Implicitly met expectations for substantial equivalence)
Surface Hardness	Tested (Implicitly met expectations for substantial equivalence)
Working Time	Tested (Implicitly met expectations for substantial equivalence)
Self-Curing Time	Tested (Implicitly met expectations for substantial equivalence)

2. Sample size used for the test set and the data provenance:

Sample size: Not specified. Standard biocompatibility tests and material property tests typically use a predefined number of samples as per the relevant ISO or ASTM standards, but the exact count is not given in this summary.
Data provenance: Not explicitly stated but assumed to be from laboratory testing as per the ISO standards mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a material testing conformity rather than a diagnostic device requiring expert interpretation of results for ground truth. Biocompatibility and mechanical property tests have objective readouts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. Adjudication methods are relevant for subjective interpretations, which are not involved in these types of material tests.

5. 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:

Not Applicable. This is not an AI-driven device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an AI-driven device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For biocompatibility: Ground truth is established by the specific, objective criteria defined within each ISO standard (e.g., cell viability percentages, absence of specific reactions).
For non-clinical performance (mechanical properties): Ground truth is established by physical measurement against established material science parameters and comparison to predicate device performance.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established:

Not Applicable. As above, no training set for an AI/ML model.

Summary

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K132115

JUN 2 5 2014

・

510(k) SUMMARY

Submitter:	Parkell, Inc.300 Executive DriveEdgewood, NY 11717TEL: 631-249-1134FAX: 631-249-1242
Contact:	Robert E. Burke, VP of OperationsParkell, Inc.300 Executive DriveEdgewood, NY 11717
Submission Date:	2 July 2013
Trade Name:	Absolute Dentin II
Common Name:	Composite Resin Core Material
Classification Name:	Material, Tooth Shade, Resin (§872.3690)
Classification Product Code:	EBF
Predicate Devices:	D/C CORE MATERIAL (K010475), BUILD-IT FR (K000211), DC CORE (K984097)
Device Description:	A dual-cure, composite resin, core build-up material that is usuallyused to restore missing tooth structure for which a dental restoration,usually a crown, is fabricated. It is substantially equivalent to manypredicate materials that include self-, light-, and dual-cure types.This material incorporates fluoride-containing (trace amounts) glassfiller particles. No Bisphenol-A or its precursors are used in themanufacturing process. The material is supplied in light-safe dual-barrel cartridges.
Indications for Use:	Absolute Dentin II is a dual-cure, composite resin core build-upmaterial that is usually used to restore missing tooth structure forwhich a dental restoration, usually a crown, is fabricated.
Tech. Characteristics:	ABSOLUTE DENTIN II is a two-paste material generally supplied ina dual-barrel cartridge, each to be expressed through disposablemixing tips.
	Absolute Dentin II	Absolute Dentin

	Absolute Dentin II	Absolute Dentin
Indications for Use:	A dual-cure, composite resin core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown, is fabricated.	A dual-cure, composite resin, core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown is fabricated. This material is of the dual-cure variety and incorporates fluoride-containing glass filler particles.

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Filler:	Silanated Silica	Silanated Silica
Matrix:	Methacrylate based resin matrix	Methacrylate based resin matrix
Compatibility:	baseddentalMethacrylateadhesives	Methacrylatebaseddentaladhesives
Method of Cure:	Both self-cure & photo initiator	Both self-cure & photo initiator
Depth of Cure:	Tooth Shade - 5.2mmWhite Shade - 4.0mm	3.5 mm
Delivery Method:	5ml dual-barrel cartridge	50ml dual-barrel cartridge10ml dual-barrel cartridge
Difference in Materials:	Bisphenol-A or its precursors werenot used in the manufacturingprocess.	Contains Ethoxylated Bisphenol ADimethacrylate

Biocompatibility:

ABSOLUTE DENTIN II has been fully tested for biocompatibility in accordance with ISO and FDA guidelines. All tests were passed according to their protocols.

Standard	Test
ISO 10993-5, 2009, Biological Evaluation of MedicalDevices - Part 5: Tests for In Vitro Cytotoxicity	L929 MEM Elution Test - ISO: Toxicon FinalGLP Report #12-5730-G1, dated 12/24/12
ISO 10993-3, 2003, Biological Evaluation of MedicalDevices - Part 3: Tests for Genotoxicity,Carcinogenicity and Reproductive Toxicity	Salmonella Typhimurium and EscherichiaColi Reverse Mutation Assay - ISO: ToxiconFinal GLP Report #12-5730-G5, dated1/10/2013
ISO 10993-10, 2010, Biological Evaluation ofMedical Devices - Part 10: Tests for Irritation andSkin Sensitization	Intracutaneous Injection Test - ISO: ToxiconFinal GLP Report #12-5730-G3, dated1/11/2013
ISO 10993-10, 2010, Biological Evaluation ofMedical Devices - Part 10: Tests for Irritation andSkin Sensitization	Kligman Maximization Test - ISO: ToxiconFinal GLP Report #12-5730-G4, dated2/19/2013
ISO 10993-10, 2010, Biological Evaluation ofMedical Devices - Part 10: Tests for Irritation andSkin Sensitization	Oral Irritation Test - Acute Exposure - ISO:Toxicon Final GLP Report #12-5730-G2,dated 2/6/2013

Substantial Equivalence: Parkell's ABSOLUTE DENTIN II composite resin core material has similar indications, principles of operation and technological characteristics as the predicate devices. The minor differences in the device (primarily the absence of Bisphenol-A and its precursors in the manufacturing process) do not raise any new questions of safety or effectiveness. Thus, ABSOLUTE DENTIN II is substantially equivalent to its predicate devices.

Non-Clinical Performance Testing:

Properties Tested- Flexural Strength, Compressive Strength, Surface Hardness, Working Time & Self-Curing Time

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Image /page/2/Picture/0 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 tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 25, 2014

Parkell, Incorporated Mr. Robert E. Burke Vice President, Operations 300 Executive Drive Edgewood, NY 11711

Re: K132115

Trade/Device Name: Absolute Dentin II Regulation Number: 21 CFR 872.3690 Regulation Name: Material, Tooth Shade, Resin · Regulatory Class: II Product Code: EBF Dated: May 23, 2014 Received: May 27, 2014

Dear Mr. Burke:

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 10 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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Page 2 - Mr. Burke

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Mary S. Runner -S

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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K132115

Indications for Use

510(k) Number (if known):

Device Name: Absolute Dentin II

Indications for Use:

A dual-cure, composite resin core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown, is fabricated.

Prescription Use × (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green -S 2014.06.23 08:45:08 -04'00'

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.