Spee-Dee Patch is a visible light cured, glass-filled resin that is intended as a vital tooth build-up material where restorations were removed and must be built up for crown preparation; as a non-vital tooth post and core; as a build up material; and as a repair material to repair fractured cusps, lost partial or whole fillings, chipped crowns, broken teeth, crowns, or bridges.

Device Description

AI/ML Overview

The provided submission describes a dental material, Spee-Dee Patch, and outlines its performance characteristics based on bench testing. The information does not pertain to an AI/ML powered device, therefore many of the requested fields are not applicable.

Here's an analysis of the provided text against your criteria:

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

Acceptance Criteria	Reported Device Performance
Light Cure Setting Time	< 20 seconds
Working time in ambient light	> 5 minutes
Clinical depth of cure	> 4 mm
Compressive Strength	45,240 ± 3480 p.s.i. / 312.0 ± 24.0 MPa
Specific gravity	1.520
Flexural Strength	13,775 ± 1450 p.s.i. / 95.0 ± 10.0 MPa
Diametral Tensile Strength	7540 ± 290 p.s.i. / 52.0 ± 2.0 MPa
Shelf-life	Two years

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each of the performance tests. The data provenance (country of origin, retrospective/prospective) is also not specified. These are "bench" tests, implying laboratory-based evaluations.

3. 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)

Not applicable. This is a material science characterization, not an diagnostic/AI device requiring expert ground truth for interpretation.

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

Not applicable. This is a material science characterization.

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-powered device.

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

Not applicable. This is not an AI-powered device.

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

The "ground truth" for the performance tests appears to be established through standardized physical and chemical testing methods appropriate for dental materials. This would be based on direct measurement against established material science standards, not expert consensus or clinical outcomes in the traditional sense of diagnostic devices.

8. The sample size for the training set

Not applicable. This device is a material, not an AI/ML model that requires a training set.

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

Not applicable. This device is a material, not an AI/ML model that requires a training set.

Summary

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K 113617

PULPDENT CORPORATION

80 Qakland Street Watertown, MA 02472 USA

MAR - 2 2012

Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Kenneth J. Berk 80 Oakland Street Watertown, MA 02472 USA Telephone: 617-926-6666 Fax: 617-926-6262 Email: ken@pulpdent.com

DEVICE:

Trade Name: Pulpdent Spee-Dee™ Patch Classification Name: Tooth shade resin material FDA Product Code: 76 EBF, 21 CFR Part 872,3690

PREDICATE DEVICES:

Pulpdent Embrace™Dual Cure Composite Materials Pulpdent Embrace™ Pit and Fissure Sealant Kuraray Clearfil™ Photo Core

DESCRIPTION AND INTENDED USE:

COMPARISON WITH PREDICATE PRODUCTS:

Spee-Dee Patch is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above. Spee-Dee Patch contains the same Embrace technology and resin composition as Embrace Pit and Fissure Sealant and Embrace Dual Cure Composite Materials (marketed as Spee-Dee™ Build-Up), except that Spee-Dee has dual cure chemistry.

Pulpdent Spee-DeePatch	Visible light-cure, resin-based,flowable material thatcontains no Bisphenol A.	Used to patch teeth or corepreparations and as a corebuild-up material.	Embrace Monomer MixPhoto-initiatorFiller: Barium glass and submicron silica
Pulpdent Spee-DeeBuild-Up MaterialK 071278	Dual-cure, resin-basedmaterial that contains noBisphenol A.	Build-up and repair material.	Embrace Monomer MixPhoto-initiatorChemical initiatorFiller: Barium glass and submicron silica
Pulpdent Embrace™Pit & Fissure SealantK 020287	Hydrophilic, visible light-cure,resin-based material thatcontains no Bisphenol A.	Seals the pits and fissures inteeth.	Embrace Monomer MixPhoto-initiatorFiller: Barium glass and submicron silica
Kuraray Clearfil™Photo CoreK882006	Light cured, resin-basedcomposite.	Build-up and repair material	Monomer MixPhoto-initiatorFiller

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PULPDENT CORPORATION

0 Oakland Street Watertown, MA 02472 IISA

Summary of Performance Testing - Bench

The following test results demonstrate that Spee-Dee Patch performs as intended:

Light Cure Setting Time	< 20 seconds
Working time in ambient light	> 5 minutes
Clinical depth of cure	> 4 mm
Compressive Strength	45,240 ± 3480 p.s.i. / 312.0 ± 24.0 MPa
Specific gravity	1.520
Flexural Strength	13,775 ± 1450 p.s.i. / 95.0 ± 10.0 MPa
Diametral Tensile Strength	7540 ± 290 p.s.i. / 52.0 ± 2.0 MPa
Shelf-life	Two years

SAFETY AND EFFECTIVENESS:

From the above comparisons, the bench testing and the ten years organizational experience with Embrace resins, it can be concluded that Spee-Dee Patch is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.

The predicate products have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3690, 872.3275 and have been on the market for years with no reports of safety or effectiveness issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Mr. Kenneth J. Berk Director of Research Pulpdent Corporation 80 Oakland Street Watertown, MA 02472

Re: K113617

Trade/Device Name: Spee-Dee™ Patch Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF Dated: December 1, 2011 Received: December 7, 2011

Dear Mr. Berk:

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 Eederal Register.

MAR - 2 2012

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Page 2 - Mr. Berk:

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 /ucm115809.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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INDICATIONS FOR USE

510 (k) Number:

K113617

Device Name:

PULPDENT SPEE-DEE™ PATCH

Indications for Use:

Prescription Use X or (Part 21 CFR 801 Subpart D)

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

Please do not write below this line. Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Curry

(Division Sign-Üff) Division of Anesthesiology, General Hospital Infection Control, Denial Devices

510(k) Number: K113617

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.