ACTIVA PRESTO PACK

K210045 · Pulpdent Corporation · EBF · Sep 22, 2021 · Dental

Device Facts

• Record ID: K210045
• Device Name: ACTIVA PRESTO PACK
• Applicant: Pulpdent Corporation
• Product Code: EBF · Dental
• Decision Date: Sep 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

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 Story

ACTIVA PRESTO PACK is a light-cure, packable composite restorative material used by dental professionals in clinical settings. It consists of a urethane-based resin matrix containing calcium, phosphate, and fluoride. The device is dispensed via multi-dose screw-type syringes or unit-dose capsules. Upon irradiation with visible light (20 ± 2 seconds), the material polymerizes to form a hard composite. The device is designed to release calcium, phosphate, and fluoride ions into the oral environment, facilitated by modified calcium phosphate (MCP) filler. It is used for various restorative procedures, including cavity filling, core build-ups, and splinting. The material's packable consistency allows for sculpting during placement. By providing a durable, wear-resistant, and bioactive restorative, the device aids in tooth structure repair and maintenance of oral health.

Clinical Evidence

Bench testing only. Performance data provided includes physical properties: filler content (80%), specific gravity (2.165 g/ml), depth of cure (2.42 mm), flexural strength (105.6 MPa), flexural modulus (7.4 GPa), compressive strength (253 MPa), and polymerization shrinkage (2.1%). Biocompatibility testing conducted per ISO 10993-1:2018 and ISO 7405:2018.

Technological Characteristics

Resin-based composite; contains diurethane dimethacrylate, Bis(2-(Methacryloyloxy) Ethyl) Phosphate, barium glass, and modified calcium phosphate (MCP). Light-cured (20s at 2mm). Packable paste consistency. Standards: ISO 14971:2019 (Risk Management), ISO 10993-1:2018/ISO 7405:2018 (Biocompatibility), ISO 4049:2019 (Polymer-based restorative materials).

Indications for Use

Indicated for dental professionals as a filling material for pits, root surface cavities, and Class I, II, III, IV, and V restorations, including direct anterior/posterior restorations, core build-ups, splinting, and indirect restorations (crowns, inlays, onlays, veneers). Contraindicated for direct placement on exposed pulp.

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

• Pulpdent ACTIVA Presto (K153249)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| <span style="font-family:Wingdings;">X</span> Prescription Use (Part 21 CER 801 Subpart D) | <span style="font-family:Wingdings;">☐</span> Over-The-Counter Use (21 CER 801 Subpart C) |

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## PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

Tel: [phone] Fax: [phone] Email: [e-mail]

### 510(k) SUMMARY

K210045

### DATE OF SUBMISSION: December 22, 2020

### OWNER: Pulpdent Corporation

## CONTACT:

Lewis W. Berk 80 Oakland Street Watertown, Massachusetts 02472 Tel: [phone] Email: [e-mail]

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:

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.

### 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™<br>K153249 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Recommended: Class II Dental Device<br>CFR 872.3690 Tooth shade resin material<br>Product Code EBF | Class II Dental Device<br>CFR 872.3690 Tooth shade resin material<br>Product 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,<br>Bis(2-(Methacryloyloxy) Ethyl) Phosphate;<br>Fillers: Barium glass, MCP (Modified calcium phosphate)<br>Photoinitiator: Camphorquinone | Resins: Diurethane dimethacrylate,<br>Bis(2-(Methacryloyloxy) Ethyl) Phosphate;<br>Fillers: Barium glass, MCP (Modified calcium phosphate)<br>Photoinitiator: Camphorquinone |
| | Pulpdent<br>ACTIVA™ PRESTO™ PACK | Pulpdent ACTIVA™ PRESTO™<br>K153249 |
| Technology | When irradiated by visible light, the resins and fillers<br>react with the photoinitiator and polymerize to form a<br>hard composite.<br>Designed to release calcium, phosphate and fluoride<br>ions into the oral environment. This calcium and<br>phosphate release is accomplished through MCP,<br>modified calcium phosphate filler | When irradiated by visible light, the resins and fillers<br>react with the photoinitiator and polymerize to form a<br>hard composite.<br>Designed to release calcium, phosphate and fluoride<br>ions into the oral environment. This calcium and<br>phosphate release is accomplished through MCP,<br>modified calcium phosphate filler. |
| Light cure | 20 ± 2 seconds in 2 mm increments | 20 seconds in 2 mm increments |
| Dispensing<br>system | Multi-dose, screw-type composite syringes<br>Unit-dose capsules | Multi-dose, push syringes (1ml, 3 ml) + applicator tips<br>Unit-dose capsules |
| Standards | Risk Management ISO 14971:2019<br>Biocompatibility ISO 10993-1:2018-08; ISO 7405:2018<br>Polymer-based restorative materials: ISO 4049:2019 | Risk Management ISO 14971:2019<br>Biocompatibility ISO 10993-1:2018-08; ISO 7405:2018<br>Polymer-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 |
| | Pulpdent<br>ACTIVA™ PRESTO™ PACK | Pulpdent ACTIVA™ PRESTO™<br>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: [phone]
PULPDENT CORPORATION - Fax: [phone]
Fax: [phone] 62817 926 6286
Email: Email: [e-mail]

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80 Oakland Street
Watertown, MA 02472
USA

# PULPDENT CORPORATION TION TION 666888
PULPDENT CORPORATION - Fax: [phone]
- Fax: [phone] 62617 926 6262

Tel: [phone]
Fax: [phone]
Email: [e-mail]