ABSOLUTE DENTIN 2

K132115 · Parkell, Inc. · EBF · Jun 25, 2014 · Dental

Device Facts

• Record ID: K132115
• Device Name: ABSOLUTE DENTIN 2
• Applicant: Parkell, Inc.
• Product Code: EBF · Dental
• Decision Date: Jun 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Absolute Dentin II is a dual-cure, composite resin core build-up material used by dental professionals to restore missing tooth structure. The material consists of a methacrylate-based resin matrix with silanated silica filler particles and trace amounts of fluoride. It is supplied in light-safe, dual-barrel cartridges and expressed through disposable mixing tips. The material cures via both self-cure and photo-initiator mechanisms. It is applied by a dentist in a clinical setting to build up a tooth core, providing a foundation for a subsequent crown restoration. The device benefits the patient by restoring structural integrity to damaged teeth. No Bisphenol-A or its precursors are used in the manufacturing process.

Clinical Evidence

Bench testing only. Performance testing included flexural strength, compressive strength, surface hardness, working time, and self-curing time. Biocompatibility testing was conducted in accordance with ISO 10993-3, ISO 10993-5, and ISO 10993-10, including cytotoxicity, genotoxicity, and irritation/sensitization assays. All tests passed.

Technological Characteristics

Dual-cure composite resin core build-up material. Matrix: Methacrylate-based resin. Filler: Silanated silica with trace fluoride. Delivery: Dual-barrel cartridge with disposable mixing tips. Curing: Self-cure and photo-initiator. Biocompatibility: Tested per ISO 10993-3, 5, and 10.

Indications for Use

Indicated for patients requiring restoration of missing tooth structure prior to fabrication of a dental restoration, typically a crown.

Regulatory Classification

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.

Predicate Devices

• D/C CORE MATERIAL (K010475)
• BUILD-IT FR (K000211)
• DC CORE (K984097)

Submission Summary (Full Text)

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K132115

·

# JUN 2 5 2014

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## 510(k) SUMMARY

| Submitter: | Parkell, Inc.<br>300 Executive Drive<br>Edgewood, NY 11717<br>TEL: [phone]<br>FAX: [phone] | |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Contact: | Robert E. Burke, VP of Operations<br>Parkell, Inc.<br>300 Executive Drive<br>Edgewood, 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 usually<br>used to restore missing tooth structure for which a dental restoration,<br>usually a crown, is fabricated. It is substantially equivalent to many<br>predicate materials that include self-, light-, and dual-cure types.<br>This material incorporates fluoride-containing (trace amounts) glass<br>filler particles. No Bisphenol-A or its precursors are used in the<br>manufacturing process. The material is supplied in light-safe dual-<br>barrel cartridges. | |
| Indications for Use: | Absolute Dentin II is a dual-cure, composite resin core build-up<br>material that is usually used to restore missing tooth structure for<br>which a dental restoration, usually a crown, is fabricated. | |
| Tech. Characteristics: | ABSOLUTE DENTIN II is a two-paste material generally supplied in<br>a dual-barrel cartridge, each to be expressed through disposable<br>mixing 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: | based<br>dental<br>Methacrylate<br>adhesives | Methacrylate<br>based<br>dental<br>adhesives |
| Method of Cure: | Both self-cure & photo initiator | Both self-cure & photo initiator |
| Depth of Cure: | Tooth Shade - 5.2mm<br>White Shade - 4.0mm | 3.5 mm |
| Delivery Method: | 5ml dual-barrel cartridge | 50ml dual-barrel cartridge<br>10ml dual-barrel cartridge |
| Difference in Materials: | Bisphenol-A or its precursors were<br>not used in the manufacturing<br>process. | Contains Ethoxylated Bisphenol A<br>Dimethacrylate |

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 Medical<br>Devices - Part 5: Tests for In Vitro Cytotoxicity | L929 MEM Elution Test - ISO: Toxicon Final<br>GLP Report #12-5730-G1, dated 12/24/12 |
| ISO 10993-3, 2003, Biological Evaluation of Medical<br>Devices - Part 3: Tests for Genotoxicity,<br>Carcinogenicity and Reproductive Toxicity | Salmonella Typhimurium and Escherichia<br>Coli Reverse Mutation Assay - ISO: Toxicon<br>Final GLP Report #12-5730-G5, dated<br>1/10/2013 |
| ISO 10993-10, 2010, Biological Evaluation of<br>Medical Devices - Part 10: Tests for Irritation and<br>Skin Sensitization | Intracutaneous Injection Test - ISO: Toxicon<br>Final GLP Report #12-5730-G3, dated<br>1/11/2013 |
| ISO 10993-10, 2010, Biological Evaluation of<br>Medical Devices - Part 10: Tests for Irritation and<br>Skin Sensitization | Kligman Maximization Test - ISO: Toxicon<br>Final GLP Report #12-5730-G4, dated<br>2/19/2013 |
| ISO 10993-10, 2010, Biological Evaluation of<br>Medical Devices - Part 10: Tests for Irritation and<br>Skin Sensitization | Oral Irritation Test - Acute Exposure - ISO:<br>Toxicon Final GLP Report #12-5730-G2,<br>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 [phone] or [phone] 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 [phone] or [phone] 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'

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