The DRFP ProSmart Root Canal Obturation System is designed for permanent sealing of root canals following established endodontic procedures by qualified healthcare professionals. The ProSmart Root Canal Obturation System is intended for Prescription Use.

Device Description

The ProSmart Root Canal Obturation System is using hydrophilic polymer technology. This causes the material to expand into irregularities and tubules of the root canal to assure a tight mechanical seal with the dentine. The hydrophilic properties of the system allow extraction without softeners in revision procedures. The system consists of ProPoint Obturation Points and ProRes Paste.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the DRFP ProSmart Root Canal Obturation System, based on the provided document:

DRFP ProSmart Root Canal Obturation System Performance Summary

1. Acceptance Criteria and Reported Device Performance

The non-clinical performance tests for the ProRes Sealer adhere to ISO 6876:2001 & ANSI/ADA Specification #57. For the ProSmart System and ProPoint Obturation Points, adherence to ISO 6877:2006 and ADA/ANSI Specification #78, along with device-specific tests, formed the basis of acceptability.

Parameter (ProRes Sealer)	Acceptable Limit (ISO 6876:2001 & ANSI/ADA Specification #57)	Reported Results
Flow	Not less than 20mm	44mm
Working time	Not less than 90% stated by manufacturer	35 mins at 37°C
Setting time	Within range stated by manufacturer	45 mins at 37°C
Film thickness	Not more than 50 µm	3.3 µm
Solubility	Shall not exceed 3%	0.0324%
Radiopacity	Not less than 3mm Al equivalent	5.4mm Al equivalent

Additional ProSmart System Acceptance Criteria & Performance:

Expansion on Hydration (ProPoints coated with ProRes): Expand up to 20%. Reported: ProPoints coated with ProRes expand up to 20%.
Resistance to Tooth Cracking (Worst Scenario Bench Test): Insertion of ProRes-coated ProPoints in heat-sterilized extracted teeth (more brittle and desiccated than patients' teeth) should show no sign of cracking or damage due to product expansion. Reported: Showed no sign of cracking or damage due to product expansion.
Exposure to Sodium Hypochlorite: No effect on safety and effectiveness if the manufacturer's recommendation to rinse the canal three times prior to insertion is followed, resulting in a remaining value of 0.01% sodium hypochlorite. Reported: The remaining value of 0.01% sodium hypochlorite will have no effect on the safety and effectiveness of the device.
Exposure to EDTA: No effect from undiluted 17% EDTA. Reported: Undiluted 17% EDTA has shown to have no effect on the system.
Radiopacity (ProSmart System): Adequate radiopacity for the intended purpose (verify point location, working length, no apex penetration, and assessment of healing). Reported: Extensive testing and continuous interaction with practicing dentists after three years of use in Europe demonstrate adequate radiopacity.

ProPoint Obturation Points Acceptance Criteria & Performance:

ISO 6877:2006 Compliance: Full compliance with all applicable performance testing of this standard. Reported: All applicable performance testing showed the points to be in full compliance with this standard.
ADA/ANSI Specification #78 Compliance: Compliance with all relevant requirements. Reported: DRFP ProPoints comply with all relevant requirements.
Device-Specific Material Differences: ProPoints differ from Gutta Percha in color (white core and translucent coating) and radiopacity (radiopaque core and radiolucent coating), yet are visible when x-rayed for effectiveness verification. Reported: ProPoints are visible in the filled root canal when x-rayed so that the endodontist can verify the effectiveness of the obturation.

Clinical Evaluation Acceptance Criteria & Performance (assessed after one year of a three-year investigation):

Healed Periapical Tissue: Positive clinical outcome. Reported: 33% healed.
Improved Periapical Tissue: Positive clinical outcome. Reported: 35% improved.
Same Periapical Tissue: Acceptable outcome (not worsened). Reported: 25% same periapical tissue.
Widening of Periodontal Ligament: Identified as not an effect of the ProSmart system but an assessment of tissue state. Reported: 6% widening of the periodontal ligament.
Symptom-free and in function: All treated teeth should meet this criterion. Reported: All teeth treated with ProSmart Root Canal Obturation System were symptom-free and in function.
No teeth extracted: Should meet this criterion. Reported: No teeth had to be extracted.
None retreated or required clinical intervention: Should meet this criterion. Reported: None had to be retreated or required a clinical intervention.

2. Sample Size and Data Provenance (Clinical Evaluation)

Sample Size for Test Set: Not explicitly stated as a number of patients or teeth. The description refers to "Radiographic images of an on-going, controlled three-year investigation."
Data Provenance: The clinical evidence is based on "three (3) years of use in Europe," suggesting retrospective data collection from European clinical practice for confirming findings. The "on-going, controlled three-year investigation" itself is a prospective study design.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: The clinical evaluation was done to "evaluate the ease of use by operating dentists, the handling characteristics and the specific root filling techniques." This implies evaluation by practicing dentists, but their specific qualifications (e.g., years of experience, specialization) are not detailed.

4. Adjudication Method

Adjudication Method: Not specified. The reported outcomes ("healed," "improved," "same," "widening") suggest a consensus or independent assessment by the "operating dentists" or researchers involved in the "controlled three-year investigation," but the method is not explicitly stated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a multi-reader multi-case comparative effectiveness study comparing human readers with AI vs. without AI assistance was not mentioned or performed. This is a medical device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

Standalone Performance: No, a standalone algorithm-only performance study was not performed. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used (Clinical Evaluation)

Ground Truth: The clinical evaluation used radiographic images and clinical outcomes (symptom-free, in function, no extractions, no retreatments) to assess "healed," "improved," "same periapical tissue," and "widening of the periodontal ligament." This suggests a combination of radiological and clinical assessments serving as the ground truth.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is a physical medical device. There is no concept of a "training set" in the context of its development and testing as described.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of medical device.

Summary

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DRFP Ltd.

ProSmart Root Canal Obturation System

K 100248

2.	510(k) SUMMARY of Safety and Effectiveness[807.92 (c)]
2.1	Submitter [807.92 (a)(1)]DRFP Ltd.Villa FarmJack Haws LaneBARNACK, StamfordLincs.PE9 3DYUnited KingdomTelephone 44 – 1780 – 740 574Telefax 44 – 1780 – 749 168e-mail info@smart-seal.co.ukweb www.smart-seal.co.uk	OCT 2 2 2010
2.2	Submission Correspondent [807.92 (a)(1)]Dagmar MaeserBusiness Support InternationalAmstel 320-I1017 AP AMSTERDAMNetherlandsTelephone 31 – 20 – 428 9591Cell 31 – 651 41 5839Fax 31 – 20 – 201 0175e-mail bsi@xs4all.nl
2.3	Date Summary Prepared [807.92 (a)(1)]October 4, 2010
2.4	Device Names [807.92 (a)(2)]Proprietary DRFP ProSmart Root CanalObturation SystemProPoints (4%, 6%, PT, S) Obturation PointsProRes Sealer with Active Powder
	Common Root Canal Obturation Points and Sealer
	Classification Names Resin, Root Canal Filling
	Product Code/ CFR KIF Class II	CFR 872.3820
2.5	Reason for Submission [807.81(3)(i)]New Device
2.6	Predicate Devices [807.92(a)(3)]Paste K042769 ADSEAL Root Canal FillingKIF CFR 872.3820(Sponsor: Meta Biomed Company Limited)Obturation Points Class I Gutta PerchaEKM CFR 872.3850(FDA-listed by 62 manufacturers)

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K 100248

2.7 Device Description [807.92(a)(4)]

2.7.1 ProPoint Obturation Points

ProPoints are offered in the traditional 4% and 6% sizes and for use with variable taper files (such as ProTaper™ and Sendoline S5™). The radiopaque core is coated with hydrophilic, translucent material that expands radially up to 20% (6% points) while maintaining dimensional length stability.

The points are packaged in clean conditions and come individually wrapped to prevent cross-contamination. They can be cut to exact tip size and length.

No heating or compression equipment is required. Post insertion can commence immediately after root canal has been filled.

ProPoints are coated with ProRes paste prior to insertion into the root canal.

ProRes Paste 2.7.2

Is a two-component base:catalyst paste based on epoxy-amine resin chemistry. It is packaged in a dual-syringe for easy and consistent mixing.

The paste comes with a carefully formulated 'Active Powder'. Mixing a tiny scoop of this material into the prepared ProRes will provide the paste with hydrophilic properties that uses the moisture present in the root canal to expand into crevices and dentine tubules for a tight mechanical seal with the tooth dentine.

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Statement of Intended Use [807.92(a)(5)]

The DRFP ProSmart Root Canal Obturation System is designed for permanent sealing of root canals following established endodontic procedures by qualified healthcare professionals.

The ProSmart Root Canal Obturation System is intended for Prescription Use.

Comparison with Predicate Devices [807.92(a)(6)] 2.9

2.9.1 ProPoints

Are functionally substantially equivalent to gutta percha points that have been used in endodontics for more than 100 years.

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K 100248

2.9.2 ProRes Paste

Is substantially equivalent to

K 042769 ADSEAL Root Canal Filling Meta Biomed Company Limited

2.9.3 Hydrophilic Materials in Powder and in ProPoint Coating and ProPoint Cores

Hydrophilic polymers in ProPoint coatings and in ProRes . powder are similar to polymers used in contact and intraocular lenses.
ProPoint core materials are used in dental implant abutments, ● dental bridges and crown cores as well as in surgical sutures.

2.10. Performance Data [807.92(b)]

2.10.1 Non-Clinical PerformanceTests (807.92(b)(1)

Handling & Setting Characteristics ProRes Sealer:

Parameter	Acceptable Limit(ISO 6876:2001 & ANSI/ADASpecification # 57)	Results
Flow	Not less than 20mm	44mm
Working time	Not less than 90% stated by manufacturer	35 mins at 37°C
Setting time	Within range stated by manufacturer	45 mins at 37°C
Film thickness	Not more than 50 $ \mu $ m	3.3 $ \mu $ m
Solubility	Shall not exceed 3%	0.0324%
Radiopacity	Not less than 3mm Al equivalent	5.4mm Al equivalent

ProSmart System:

1) Expansion on Hvdration

Propoints coated with prores expand up to 20%.

Worst Scenario Bench Test of Resistance to Tooth Cracking 2) Due to Hydrophilic Expansion
Insertion of prores-coated propoints in heat-sterilized extracted teeth (more brittle and desiccated than patients' teeth), showed no sign of cracking or damage due to product expansion.
Exposure to Sodium Hypochlorite 3)
The manufacturer's recommends to rinse the canal three (3) times prior to insertion of the system. If this regime is followed, the remaining value of 0.01% sodium hypochlorite will have no effect on the safety and effectiveness of the device.

Exposure to EDTA 4)

Undiluted 17% EDTA has shown to have no effect on the system.

5) Radiopacity

Extensive testing and continuous interaction with practicing dentists after three (3) years of use in Europe demonstrate adequate radiopacity for the intended purpose. The dentist is able to

verify that the obturation point is located in the correct . position and has the correct working length

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K 100248

assure that it has not penetrated the apex and as a . medical record to
assess healing

ProPoint Obturation Points:

1) ISO 6877:2006

All applicable performance testing showed the points to be in full compliance with this standard. Since the standard was developed with reference to traditional Gutta Percha points, additional device-specific testing was performed regarding:

Expansion on Hydration .
Bonding of Sheath to Core .
Flexibility .
Geometry .
Radiopacity and Analysis of Core Materials .
In-Vitro Dye Penetration and Sealing Tests .
CT Scans and X-Ray Photographs

Test results demonstrate that propoints are safe and effective for the intended purpose.

2) ADA/ANSI Specification # 78

DRFP propoints comply with all relevant requirements. Due to device-specific material differences when compared to Gutta Percha, propoints differ in

Color = white core and translucent coating
= radiopaque core and radiolucent coating Radiopacity

propoints are visible in the filled root canal when x-rayed so that the endodontist can verify the effectiveness of the obturation

2.10.2 Clinical Evaluation (807.92(b)(2)

Radiographic images of an on-going, controlled three-year investigation to evaluate the ease of use by operating dentists, the handling characteristics and the specific root filling techniques of the ProSmart System, demonstrate after one year:

33% healed ●
.
35% improved .
25% same periapical tissue .
6% widening of the periodontal ligament (This is an assessment of . the state of tissue surrounding the base of the tooth and not an effect caused by the ProSmart system)

All teeth treated with ProSmart Root Canal Obturation System, were

symptom-free and in function; .
No teeth had to be extracted .
None had to be retreated or required a clinical intervention .

Clinical evidence after close to three (3) years of use in Europe confirms these findings.

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. ProSmart Root Canal Obturation System Traditional 510(k) ...

.. . . . . . . . . . . . . . . .

K 100248

বিশ্ববিদ্যালয়ের পরিবর্তন বিশ্বকাপ বিশ্বকাপ বিশ্বকাপ বিশ্বকাপ করে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পা

・・・・・・

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Contraindications

DRFP Ltd.

् The manufacturer recommends to not use the system in pregnant women and in nursing mothers.

...

. .

Information Bearing on Safety and Effectiveness

(807.92 (b)(3)]

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

: The matarials used in the DRFP ProSmart Root Canal Obturation System have a long history of safe and effective use in dental and other medical : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : devices.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Biocompatibility testing according to ISO 10993 and ISO 7405 has shown the material to be non-toxic, non-carcinogenic and biocompatible with the maturial in There are no characteristics known that should adversely affect the safety and effectiveness of this device :

... . ........................................................................................................................................................................ : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : . Test data demonstrate that the DRFP ProSman Root Canal Obtureting System is substantially equivalent to its predicates. .

The results of design validation and non-clinical and clinical performance testing raise no new issues of safety and effectiven

8/10/10
Date

Jerry Watson, BDS
CEO

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: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

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Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all capital letters. The text is black and the background is white. The text is centered in the image and is the only element present.

Public Health Service

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

DRFP Limited C/O Ms. Dagmar Maeser Maeser Business Support International, V.O.F. Amstel 320-I 1017 AP Amsterdam Netherlands

OUT 2 2 2010

Re: K100248

Trade/Device Name: DRFP ProSmart Root Canal Obturation System - ProPoint 4%, 6%, PT, S Obturation Points - ProRes Root Canal Sealer ' Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: October 8, 2010 Received: October 12, 2010

Dear Ms. Maeser:

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 Federal Register.

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Page 2- Ms. Maeser

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 (OS) regulation (21 CFR Parl 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.

fim

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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INDICATION-FOR-USE K 100248 510(k) Number (if known): OCT 2 2 2010 Device Name: DRFP ProSmart Root Canal Obturation System ProPoint 4%, 6%, PT, S -Obturation Points ProRes Root Canal Sealer

INDICATION FOR USE:

The DRFP ProSmart Root Canal Obturation System is designed for permanent sealing of root canals following established endodontic procedures by qualified healthcare professionals.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Susan Rumos

(Division Sign-Off) (Division Sign-Oh)
Division Sign-Only Division of Anoothoon
Intection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.