(268 days)
Not Found
No
The summary describes a root canal obturation system based on hydrophilic polymer technology and provides performance data related to material properties and clinical outcomes. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of AI/ML.
Yes
Explanation: The device is used for permanent sealing of root canals to treat and improve the condition of periapical tissue, which falls under therapeutic use.
No
The device is described as an "Obturation System" for "permanent sealing of root canals," which indicates it is used for treatment/therapy, not diagnosis. The performance studies also focus on material properties and clinical outcomes of sealing, not diagnostic capabilities.
No
The device description clearly states it is a "Root Canal Obturation System" consisting of "ProPoint Obturation Points and ProRes Paste," which are physical materials used in a medical procedure. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "permanent sealing of root canals following established endodontic procedures." This is a therapeutic procedure performed directly on a patient's body.
- Device Description: The device is a system for filling root canals, consisting of obturation points and paste. This material is placed inside the patient's tooth.
- Lack of In Vitro Testing: While there are non-clinical performance tests, these are evaluating the physical and chemical properties of the material itself and its interaction with tooth structure, not analyzing a sample taken from the body to diagnose a condition. The clinical evaluation is also observing the outcome of the treatment on patients.
- No Mention of Analyzing Samples: There is no indication that this device is used to analyze blood, urine, tissue, or any other sample taken from the body outside of the body.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is used in the body as part of a treatment procedure.
N/A
Intended Use / Indications 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.
The ProSmart Root Canal Obturation System is intended for Prescription Use.
Product codes (comma separated list FDA assigned to the subject device)
KIF
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified healthcare 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)
Non-Clinical PerformanceTests (807.92(b)(1)
Handling & Setting Characteristics ProRes Sealer:
| Parameter | Acceptable Limit
(ISO 6876:2001 & ANSI/ADA
Specification # 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 µm | 3.3 µm |
| 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
- 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.
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
§ 872.3820 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.
0
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 Farm
Jack Haws Lane
BARNACK, Stamford
Lincs.
PE9 3DY
United Kingdom
Telephone 44 – 1780 – 740 574
Telefax 44 – 1780 – 749 168
e-mail info@smart-seal.co.uk
web www.smart-seal.co.uk | OCT 2 2 2010 |
| 2.2 | Submission Correspondent [807.92 (a)(1)]
Dagmar Maeser
Business Support International
Amstel 320-I
1017 AP AMSTERDAM
Netherlands
Telephone 31 – 20 – 428 9591
Cell 31 – 651 41 5839
Fax 31 – 20 – 201 0175
e-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 Canal
Obturation System
ProPoints (4%, 6%, PT, S) Obturation Points
ProRes 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 Filling
KIF CFR 872.3820
(Sponsor: Meta Biomed Company Limited)
Obturation Points Class I Gutta Percha
EKM CFR 872.3850
(FDA-listed by 62 manufacturers) | |
1 | Page e
.
ﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
1
K 100248
2.7 Device Description [807.92(a)(4)]
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.
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.
Image /page/1/Picture/13 description: The image shows the number 2.8 in bold font. The number is positioned at the top of the image. There is a curved line below the number.
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.
2 | P ก แ บ บ
2
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/ADA
Specification # 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
3
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.
Image /page/3/Figure/32 description: The image shows the number 4 followed by the word "Page". The number 4 is on the left side of the image, and the word "Page" is on the right side of the image. The text is in a simple, sans-serif font.
4
. 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
・・・・・・
9
: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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)]
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
r
: 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
..............................................................................................................................................................................
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
::.:::::::::.:...... :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
5
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.
6
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
7
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)
1