(257 days)
Not Found
No
The description focuses on the material properties and intended use as a dental filling, with no mention of AI or ML capabilities.
No.
This device is a dental filling material, which is used for restorative procedures rather than to treat or cure a disease or condition.
No
The device is described as a dental filling material and restorative material, not for diagnosing conditions.
No
The device description clearly states it is a "material" and a "packable, highly polishable" substance, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "dental filling material" for various restorative procedures performed on the patient's teeth.
- Device Description: The description details its composition as a "light cure material that contains calcium, phosphate, and fluoride in a durable, wear-resistant resin matrix." This is consistent with a material used for physical restoration.
- Anatomical Site: The anatomical sites are specific parts of the teeth (pits, cavities, etc.).
- Intended User: The intended users are "dental professionals" who apply the material directly to the patient.
IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device is applied within the body for a restorative purpose.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
EBF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of physical properties with predicate device:
- Filler: 80.0%
- Resins: 20.0%
- Specific gravity: 2.165 g/ml
- Depth of cure: 2.42 mm
- Flexural strength: 105.6 MPa
- Water sorption: 34.5 µg/mm³
- Solubility: 7.2 µg/mm³
- Radio-opacity: 2.92 mm Al
- Flexural modulus: 7.4 ± 0.5 GPa
- Deflection at break: 0.54 mm
- Compressive strength: 253 ± 25 MPa
- Diametral tensile strength: 47.6 ± 5.7 MPa
- Polymerization shrinkage: 2.1%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
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3
PULPDENT CORPORATION
80 Oakland Street Watertown, MA 02472 USA
Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com
510(k) SUMMARY
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:
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).
4
80 Oakland Street
Watertown, MA 02472
USA
PULPDENT CORPORATION TION
| | Pulpdent ACTIVA™ PRESTO™ PACK | Pulpdent ACTIVA™ PRESTO™
K153249 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Recommended: Class II Dental Device
CFR 872.3690 Tooth shade resin material
Product Code EBF | Class II Dental Device
CFR 872.3690 Tooth shade resin material
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,
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 |
| | Pulpdent
ACTIVA™ PRESTO™ PACK | Pulpdent ACTIVA™ PRESTO™
K153249 |
| Technology | When irradiated by visible light, the resins and fillers
react with the photoinitiator and polymerize to form a
hard composite.
Designed to release calcium, phosphate and fluoride
ions into the oral environment. This calcium and
phosphate release is accomplished through MCP,
modified calcium phosphate filler | When irradiated by visible light, the resins and fillers
react with the photoinitiator and polymerize to form a
hard composite.
Designed to release calcium, phosphate and fluoride
ions into the oral environment. This calcium and
phosphate release is accomplished through MCP,
modified calcium phosphate filler. |
| Light cure | 20 ± 2 seconds in 2 mm increments | 20 seconds in 2 mm increments |
| Dispensing
system | Multi-dose, screw-type composite syringes
Unit-dose capsules | Multi-dose, push syringes (1ml, 3 ml) + applicator tips
Unit-dose capsules |
| Standards | Risk Management ISO 14971:2019
Biocompatibility ISO 10993-1:2018-08; ISO 7405:2018
Polymer-based restorative materials: ISO 4049:2019 | Risk Management ISO 14971:2019
Biocompatibility ISO 10993-1:2018-08; ISO 7405:2018
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
ACTIVA™ 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% |
5
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
6
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