ACTIVA PRESTO PACK is intended to be used by dental professionals as a dental filling material for pits, root surface cavities, and Class I, II, III, IV and V restorations include, but are not limited to, direct anterior and posterior restorations (including occlusal surfaces), core build-ups, splinting, and indirect restorations including crowns, inlays, onlays and veneers.

Device Description

ACTIVA PRESTO™ PACK is an aesthetic, light cure material that contains calcium, phosphate, and fluoride in a durable, wear-resistant resin matrix indicated for all restorative procedures. The material is packable, highly polishable and contains no Bisphenol A, no BisGMA and no BPA derivatives. It is available in various shades, has low solubility, low water sorption, high physical properties, and is bioactive as demonstrated within this 510(k) submission.

AI/ML Overview

The document provided is a 510(k) Premarket Notification from Pulpdent Corporation to the FDA for their device, ACTIVA PRESTO PACK. This submission focuses on demonstrating substantial equivalence to a predicate device, ACTIVA Presto (K153249), rather than presenting a study where a device's performance is measured against acceptance criteria in the format typically used for AI/ML devices.

Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training) are not applicable to the information contained in this document, as it describes a physical dental material, not an AI/ML diagnostic or assistive device.

However, I can extract the comparative performance data between the proposed device and its predicate, which serves a similar function to "acceptance criteria" in that the new device must perform comparably to the predicate.

Here's the information extracted in a modified format to fit the request where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are implied by the performance of the legally marketed predicate device. The new device "ACTIVA™ PRESTO™ PACK" is compared against "Pulpdent ACTIVA™ PRESTO™ (K153249)". Substantial equivalence is demonstrated by comparable physical properties and intended use.

Characteristic	Predicate Device (ACTIVA™ Presto™ K153249)	Proposed Device (ACTIVA™ PRESTO™ PACK)	Result/Comparison
Classification	Class II Dental Device, CFR 872.3690, EBF	Class II Dental Device, CFR 872.3690, EBF	Equivalent
Common Name	Tooth shade resin material; restorative	Tooth shade resin material; restorative	Equivalent
Description	Aesthetic, light cure material, urethane-based resin, flowable, stackable, contains calcium, phosphate, fluoride, no Bisphenol A, no BisGMA, no BPA derivatives	Aesthetic, light cure material, urethane-based resin, packable, sculptable, contains calcium, phosphate, fluoride, no Bisphenol A, no BisGMA, no BPA derivatives	Similar, with difference in handling characteristic (flowable vs. packable)
Intended Use	Light-cure, flowable composite used by dental professionals as a restorative.	Light-cure, packable composite used by dental professionals as a restorative.	Similar, with difference in handling characteristic (flowable vs. packable)
Indications for Use	Filling material for pits, root surface cavities, Class I, II, III, IV and V restorations.	Filling material for pits, root surface cavities, Class I, II, III, IV and V restorations. Includes direct anterior/posterior (occlusal), core build-ups, splinting, indirect restorations (crowns, inlays, onlays, veneers).	Expanded clarity in indications but functionally equivalent.
Contraindications	Not for direct placement on exposed pulp.	Not for direct placement on exposed pulp.	Equivalent
Composition	Resins: Diurethane dimethacrylate, Bis(2-(Methacryloyloxy) Ethyl) Phosphate; Fillers: Barium glass, MCP; Photoinitiator: Camphorquinone	Resins: Diurethane dimethacrylate, Bis(2-(Methacryloyloxy) Ethyl) Phosphate; Fillers: Barium glass, MCP; Photoinitiator: Camphorquinone	Equivalent
Technology	Light-cure polymerization, releases Ca, P, F ions.	Light-cure polymerization, releases Ca, P, F ions.	Equivalent
Light Cure	20 seconds in 2 mm increments	20 ± 2 seconds in 2 mm increments	Equivalent
Dispensing System	Multi-dose, push syringes (1ml, 3 ml) + applicator tips; Unit-dose capsules	Multi-dose, screw-type composite syringes; Unit-dose capsules	Similar
Standards	ISO 14971, ISO 10993-1, ISO 7405, ISO 4049	ISO 14971, ISO 10993-1, ISO 7405, ISO 4049	Equivalent
Appearance	Paste, various tooth shades	Paste, various tooth shades	Equivalent
Odor	Mild, characteristic	Mild, characteristic	Equivalent
Filler	70.0%	80.0%	Different
Resins	30.0%	20.0%	Different
Specific Gravity	1.820 g/ml	2.165 g/ml	Different
Depth of Cure	2.74 mm	2.42 mm	Similar
Flexural Strength	100.1 MPa	105.6 MPa	Higher (better)
Water Sorption	36.3 µg/mm³	34.5 µg/mm³	Lower (better)
Solubility	4.7 µg/mm³	7.2 µg/mm³	Higher (worse)
Radio-opacity	2.3 mm	2.92 mm Al	Higher (better)
Flexural Modulus	5.8 GPa	7.4 ± 0.5 GPa	Higher (better)
Deflection at Break	0.70 mm	0.54 mm	Lower (worse)
Compressive Strength	327.4 MPa	253 ± 25 MPa	Lower (worse)
Diametral Tensile Strength	61 MPa	47.6 ± 5.7 MPa	Lower (worse)
Polymerization Shrinkage	2.1%	2.1%	Equivalent

Study Conclusion: The submission concludes that ACTIVA™ PRESTO™ PACK is substantially equivalent to ACTIVA™ Presto™ (K153249) based on comparable design, composition, performance, and intended use. While some physical properties show variation, the overall performance profile is considered acceptable for substantial equivalence for a dental restorative material. The key difference noted is the change from a "flowable" to a "packable/sculptable" composite.

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

This information is not applicable as the document describes a physical medical device (dental filling material), not software or an AI/ML diagnostic. The performance data presented are physical and chemical properties measured in a lab setting, not clinical data from a test set of patients.

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)

This information is not applicable. Ground truth, in the context of AI/ML, refers to definitively established diagnoses or classifications. For a dental material, "ground truth" would be established by standardized laboratory testing methods, not expert consensus on diagnostic images.

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

This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of images or data, which is not the case for material property testing.

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

This information is not applicable as the device is a dental material, not an AI/ML assistive device for human readers.

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

This information is not applicable as the device is a dental material, not an algorithm.

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

The "ground truth" for the performance data in this submission is derived from standardized laboratory testing protocols as per international standards like ISO 4049:2019 for Polymer-based restorative materials. These tests define how to rigorously measure properties like flexural strength, depth of cure, water sorption, etc., ensuring reproducible and objective results.

8. The sample size for the training set

This information is not applicable as the device is a physical material, not an AI/ML device that undergoes "training."

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

This information is not applicable as the device is a physical material, not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 22, 2021

Pulpdent Corporation Lewis Berk Executive Manager 80 Oakland Street Watertown, Massachusetts 02472

Re: K210045

Trade/Device Name: Activa Presto Pack Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: May 13, 2021 Received: July 26, 2021

Dear Lewis 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210045

Device Name ACTIVA PRESTO PACK

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subpart D)	☐ Over-The-Counter Use (21 CER 801 Subpart C)

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PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

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

510(k) SUMMARY

K210045

DATE OF SUBMISSION: December 22, 2020

OWNER: Pulpdent Corporation

CONTACT:

Lewis W. Berk 80 Oakland Street Watertown, Massachusetts 02472 Tel: 617 926 6666 Email: lewberk@pulpdent.com

TYPE OF SUBMISSION: Traditional 510(k)

DEVICE:

Trade Name: ACTIVA™ PRESTO™ PACK Device Class: II Classification Name: Tooth-shade resin material FDA Product Code: EBF, 21 CFR Part 872.3690

PREDICATE DEVICES:

Pulpdent ACTIVA™ Presto, K153249

INTENDED USE:

ACTIVA™ PRESTO™ PACK is a light-cure, packable composite used by dental professionals as a restorative.

INDICATIONS FOR USE

ACTIVA™ PRESTO™ PACK is intended to be used as a filling material for pits, root surface cavities, and Class I, III, IV and V restorations. Indications include, but are not limited to, direct anterior and posterior restorations (including occlusal surfaces), core build-ups, splinting, and indirect restorations including crowns, inlays, onlays and veneers.

DESCRIPTION:

COMPARISON WITH PREDICATE PRODUCT:

Pulpdent PRESTO™ PACK is substantially equivalent in design, composition,

performance and intended use to ACTIVA™ Presto™ (K153249). The predicate product has been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3690 (Code EBF).

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80 Oakland Street
Watertown, MA 02472
USA

PULPDENT CORPORATION TION

	Pulpdent ACTIVA™ PRESTO™ PACK	Pulpdent ACTIVA™ PRESTO™K153249
Classification	Recommended: Class II Dental DeviceCFR 872.3690 Tooth shade resin materialProduct Code EBF	Class II Dental DeviceCFR 872.3690 Tooth shade resin materialProduct Code EBF
Common name	Tooth shade resin material; restorative	Tooth shade resin material; restorative
Description	Aesthetic, light cure material that contains calcium, phosphate and fluoride in a durable, wear-resistant resin matrix indicated for all restorative procedures. The material is a urethane-based resin that is packable, sculptable, highly polishable and contains no Bisphenol A, no BisGMA and no BPA derivatives.	Aesthetic, light cure material that contains calcium, phosphate and fluoride in a durable, wear-resistant resin matrix indicated for all restorative procedures. The material is a urethane-based resin that is flowable, stackable and contains no Bisphenol A, no BisGMA, and no BPA derivatives.
Intended Use	Light-cure, packable composite used by dental professionals as a restorative.	Light-cure, flowable composite used by dental professionals as a restorative.
Indications for Use	Filling material for pits, root surface cavities, and Class I, II, III, IV and V restorations. Indications include, but are not limited to, direct anterior and posterior restorations (including occlusal surfaces), core build-ups, splinting, and indirect restorations including crowns, inlays, onlays and veneers.	Universal restorative recommended as a filling material for pits, root surface cavities, and Class I, II, III, IV and V restorations.
Contraindications	Not indicated for direct placement on the exposed pulp.	Not indicated for direct placement on the exposed pulp.
Composition	Resins: Diurethane dimethacrylate,Bis(2-(Methacryloyloxy) Ethyl) Phosphate;Fillers: Barium glass, MCP (Modified calcium phosphate)Photoinitiator: Camphorquinone	Resins: Diurethane dimethacrylate,Bis(2-(Methacryloyloxy) Ethyl) Phosphate;Fillers: Barium glass, MCP (Modified calcium phosphate)Photoinitiator: Camphorquinone
	PulpdentACTIVA™ PRESTO™ PACK	Pulpdent ACTIVA™ PRESTO™K153249
Technology	When irradiated by visible light, the resins and fillersreact with the photoinitiator and polymerize to form ahard composite.Designed to release calcium, phosphate and fluorideions into the oral environment. This calcium andphosphate release is accomplished through MCP,modified calcium phosphate filler	When irradiated by visible light, the resins and fillersreact with the photoinitiator and polymerize to form ahard composite.Designed to release calcium, phosphate and fluorideions into the oral environment. This calcium andphosphate release is accomplished through MCP,modified calcium phosphate filler.
Light cure	20 ± 2 seconds in 2 mm increments	20 seconds in 2 mm increments
Dispensingsystem	Multi-dose, screw-type composite syringesUnit-dose capsules	Multi-dose, push syringes (1ml, 3 ml) + applicator tipsUnit-dose capsules
Standards	Risk Management ISO 14971:2019Biocompatibility ISO 10993-1:2018-08; ISO 7405:2018Polymer-based restorative materials: ISO 4049:2019	Risk Management ISO 14971:2019Biocompatibility ISO 10993-1:2018-08; ISO 7405:2018Polymer-based restorative materials: ISO 4049:2019
Physical properties
Appearance	Paste, various tooth shades	Paste, various tooth shades
Odor	Mild, characteristic	Mild, characteristic
Filler	80.0%	70.0%
Resins	20.0%	30.0%
Specific gravity	2.165 g/ml	1.820 g/ml
Depth of cure	2.42 mm	2.74 mm
	PulpdentACTIVA™ PRESTO™ PACK	Pulpdent ACTIVA™ PRESTO™K153249
Flexural strength	105.6 MPa	100.1 MPa
Water sorption	34.5 µg/mm³	36.3 µg/mm³
Solubility	7.2 µg/mm³	4.7 µg/mm³
Radio-opacity	2.92 mm Al	2.3 mm
Flexural modulus	7.4 ± 0.5 GPa	5.8 GPa
Deflection at break	0.54 mm	0.70 mm
Compressive strength	253 ± 25 MPa	327.4 MPa
Diametral tensile strength	47.6 ± 5.7 MPa	61 MPa
Polymerization shrinkage	2.1%	2.1%

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80 Oakland Street
Watertown, MA 02472
USA

PULPDENT CORPORATION Tel: 617 926 6666
PULPDENT CORPORATION - Fax: 617 926 6666
Fax: 617 926 62817 926 62817 926 6286
Email: Email: Pulpdent@pulpdent.com

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80 Oakland Street
Watertown, MA 02472
USA

PULPDENT CORPORATION TION TION 666888

PULPDENT CORPORATION - Fax: 617 926 66668

Fax: 617 926 62617 926 62617 926 6262

Tel: 011 326 0000
Fax: 617 926 6262
Email: pulpdent@pulpdent.com

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.