(73 days)
Not Found
No
The document describes a physical splinting system made of quartz fibers and resin, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used for oral splinting, reinforcement, and stabilization, which addresses structural support rather than treating a disease or condition in a therapeutic sense.
No
This device is a splinting system used for oral splintings, tooth stabilization, reinforcement, and repair, which are therapeutic and restorative functions, not diagnostic.
No
The device description clearly states that the device is made of physical materials (quartz fibers and resin) and is a "complete system that contains different structures," indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as a splinting system for oral use, supporting dental work, and stabilizing teeth. This is a direct application within the body (or on dental structures within the body), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the materials and structure of the splinting system, which are physical components used for mechanical support and reinforcement.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on physical, mechanical, and biological properties relevant to a dental splint, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The splinting system is designed for use in oral splintings or to support laboratory-processes composite bridge/denture work
- QUARTZ SPLINT™ UD (Unidirectional): Composite laboratory bridge strengthening/ . reinforcement
- QUARTZ SPLINT™ WOVEN: Direct Splinting/Bridge and Implant positioning . reinforcement. Splinting of mobile teeth/temporary stabilization in Clinical use. Retention of teeth subsequent to orthodontic therapy.
- QUARTZ SPLINT™ ROPE: Laboratory splint fabrication for bridge reinforcement or . denture repair. Periodontal splinting of mobile teeth in Clinical use.
- QUARTZ SPLINT™ MESH: Denture reinforcement and denture repair: #
- QUARTZ SPLINT™ RESIN: for additional wetting during the application of the finished splints
- QS FLOWTM: a nano filled, light cured flowable composite designed to be used with the . QUARTZ SPLINT system for reinforcement and stabilizing of mobile teeth.
Product codes
EBI, EBF, EBG
Device Description
Quartz Splint is made of quartz fibers impregnated a light-cured resin matrix. Quartz Splint is a complete system that contains different structures and it is available in different structures and sizes:
Quartz Splint UD
Quartz Splint WOVEN
Ouartz Splint ROPE
Quartz Splint MESH
Ouartz Splint Resin/Flow
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non-Clinical Tests: Verification and validation were conducted to ensure the expected performance of the Quartz Splint system.
Clinical Performance Data: No clinical studies were utilized for the purpose of obtaining safety or effectiveness data.
Physical and mechanical properties testing of the subject and predicate devices have been evaluated according to ISO 4049:2009. The testing results indicate that the subject and predicate device comply with the requirements of ISO 4049:2009. Internal and external tests demonstrate that QUARTZ SPLINT system compared to the predicate devices perform as well as equal or better in mechanical features which are the main function for a splint.
Biological evaluation such as cytotoxicity tests (according to ISO 10993-5) has been conducted. and results comply with the requirements.
Key Metrics
Not Found
Predicate Device(s)
K011788, K972985, K913040, K031341
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
K|22348
Image /page/0/Picture/1 description: The image shows a logo with the letters "RTD" in a stylized font on the left side. To the right of the logo are the words "RECHERCHES TECHNIQUES" stacked on top of each other. Below these words is a left-pointing triangle followed by the word "DENTAIRES". The logo and text appear to be for a dental research or technology company.
OCT 1 5 2012
510(k) Summary [As described in 21CFR 807.92]
- Submitter by: RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) 3 RUE LOUIS NEEL TECHNOPARC, ESPACE GAVANIERE 38120 SAINT EGREVE FRANCE 38120 Phone: 33-4-76565663
2. Contact Person:
Manh Quynh Chu R.T.D. 3 Rue Louis Neel St. Egreve, FRANCE 38120 Phone: 33-4-76565663
-
Date Prepared: 26-Jul-2012
-
Trade Name: Quartz Splint
5. Common Name:
- Dental splinting .
- . Tooth shade resin material21
Classification Name: 6.
- Dental/Resin, denture, relining, repairing, rebasing (21 CFR 872.3760, Product Code EBI) ●
- Material, tooth shade, resin (21 CFR 872.3690, Product Code EBF) .
7. Predicate Device(s): Device: EVERSTICK Manufacturer: STICK TECH LTD 510(k) Number: K011788
Device: SPLINT-IT Manufacturer: PENTRON INC 510(k) Number: K972985
Device: RIBBOND Manufacturer: RIBBOND Inc
Section 5- Page 1 of 3
RTD . 3, rue Louis Neel . Technoparc Espace Gavanière . 38120 SAINT-EGREVE . FRANCE Tél .: 33(0)4 76 56 56 66 . Fax: 33(0)4 76 56 11 77 . E-mail: infostiond fr . Internet: http://www.rdd.fr SARL-RCS GRENOBLE B 065 501 055/ APE 331 B / TVA Inca Nº FR 44 068 501 055
ISO 13485 (G-MED)
1
Image /page/1/Picture/0 description: The image shows a logo with the letters "RTD" in bold, black font. To the right of the logo, there is text that reads "RECHERCHES TECHNIQUES DENTAIRES" in a smaller, sans-serif font. The text is stacked vertically, with "RECHERCHES" at the top, "TECHNIQUES" in the middle, and "DENTAIRES" at the bottom. There is a small triangle pointing to the left before the word "DENTAIRES".
13. Technological characteristics:
The predicate devices are made of continuous glass fibers/polyethylene fibers. The predicate devices are offered in a dry, non-impregnated fibers or in a light-cured resin impregnated fibers. QUARTZ SPLINT have the same technological characteristics as these predicate devices as they are made of continuous quartz fibers impregnated in a light-cured resin. Polymerization or curing is the same for all these devices with help of halogen or LED dental light system. A flowable nano-hybrid, light-cured composite especially designed for use with the fiber products for the stabilization/splinting of mobile teeth is available. All predicate devices have the same intended use as QUARTZ SPLINT system.
14. Performance
Physical and mechanical properties testing of the subject and predicate devices have been evaluated according to ISO 4049:2009. The testing results indicate that the subject and predicate device comply with the requirements of ISO 4049:2009. Internal and external tests demonstrate that QUARTZ SPLINT system compared to the predicate devices perform as well as equal or better in mechanical features which are the main function for a splint.
Biological evaluation such as cytotoxicity tests (according to ISO 10993-5) has been conducted. and results comply with the requirements.
15. Conclusion
In vitro tests and clinical evaluation demonstrate that the QUARTZ SPLINT system (subject device) is substantially equivalent in safety and effectiveness to the predicate device.
Section 5- Page 3 of 3
RTD . 3; rue Louis Neel . Technoparc Espace Gavanière . 38120 SAINT-EGREVE . FRANCE Tel.: 33(0)4 76 56 56 66 - Fax: 33(0)4 76 56 11 77 - E-mail: infost@rid.fr - Internet: http://www.rdd.fr SARL-RCS GRENOBLE B 068 501 055: APE 331 B/ TVA Intra Nº FR 44 068 501 055
ISO 13485 (G-MED)
2
Image /page/2/Picture/0 description: The image shows a logo with the letters RTD in a bold, stylized font on the left side. To the right of the letters, there is text that reads "RECHERCHES TECHNIQUES DENTAIRES". The text is stacked vertically, with "RECHERCHES" on top, followed by "TECHNIQUES", and then "DENTAIRES" at the bottom. A small arrow is to the left of the word "DENTAIRES".
510(k) Number: K913040 .
Device: EVERSTICK Manufacturer: STICK TECH LTD 510(k) Number: K031341
8. Description of the Device:
Quartz Splint is made of quartz fibers impregnated a light-cured resin matrix. Quartz Splint is a complete system that contains different structures and it is available in different structures and sizes:
Quartz Splint UD Quartz Splint WOVEN Ouartz Splint ROPE Quartz Splint MESH Ouartz Splint Resin/Flow
9. Intended Use:
The splinting system is designed for use in oral splintings or to support laboratory-processes composite bridge/denture work
- QUARTZ SPLINT™ UD (Unidirectional): Composite laboratory bridge strengthening/ t reinforcement
- QUARTZ SPLINTTM WOVEN: Direct Splinting/Bridge and Implant positioning . reinforcement. Splinting of mobile teeth/temporary stabilization in Clinical use. Retention of teeth subsequent to orthodontic therapy.
- OUARTZ SPLINT™ ROPE: Laboratory splint fabrication for bridge reinforcement or . denture repair .- Periodontal splinting of mobile teeth in Clinical use.
- QUARTZ SPLINTTM MESH: Denture reinforcement and denture repair. .
- QUARTZ SPLINT™ RESIN: for additional wetting during the application of the finished . splints
- QS FLOWM: a nano filled, light cured flowable composite designed to be used with the . QUARTZ SPLINT system for reinforcement and stabilizing of mobile teeth.
10. Technological Characteristics:
The subject device has the same technological characteristics and indications for use as the predicate device.
11. Non-Clinical Tests:
・・
Verification and validation were conducted to ensure the expected performance of the Quartz Splint system.
12. Clinical Performance Data:
No clinical studies were utilized for the purpose of obtaining safety or effectiveness data.
Section 5- Page 2 of 3
RTD . 3, rue Louis Neel . Technopare Espace Gavanière . 38120 SAINT-EGREVE . FRANCE Tél.: 33(0)4 76 56 56 66 · Fax: 33(0)4 76 56 11 77 · E-mail: infos(@gd.fr · Internet: http://www.rdd.fr SARL-RCS GRENOBLE B 068 501 0554 APE 335 B / TVA Intra No FR 44 068 501 055
ISO 13485 (G-MED)
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Manh-Quynh Chu Technical Director Recherches Techniques Dentaires 3 Rue Louis Neel St. Egreve, 38120 France
Re: K122348
Trade/Device Name: Quartz Splint System (Quartz Splint UD, Quartz Splint Woven, Quartz Splint Rope, Quartz Splint Mesh, Quartz Splint Resin, and OS Flow)
Regulation Number: 21 CFR 872.3760
Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II
Product Codes: EBI, EBF, EBG
Dated: July 26, 2012
Received: August 3, 2012
Dear Mr. Chu:
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.
OCT 1 5 2012
4
Page 2 - Mr. Chu
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 (QS) regulation (21 CFR Part 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,
Anthony D. ma
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
5
Indications for Use
¥122348
510(k) Number (if known): To Be Assigned
Device Name: Quartz Splint System
Indications For Use:
The splinting system is designed for use in oral splintings or to support laboratory-processes composite bridge/denture work
- QUARTZ SPLINT™ UD (Unidirectional): Composite laboratory bridge strengthening/ . reinforcement
- QUARTZ SPLINT™ WOVEN: Direct Splinting/Bridge and Implant positioning . reinforcement. Splinting of mobile teeth/temporary stabilization in Clinical use. Retention of teeth subsequent to orthodontic therapy.
- QUARTZ SPLINT™ ROPE: Laboratory splint fabrication for bridge reinforcement or . denture repair. Periodontal splinting of mobile teeth in Clinical use.
- QUARTZ SPLINT™ MESH: Denture reinforcement and denture repair: #
- QUARTZ SPLINT™ RESIN: for additional wetting during the application of the finished � splints
- QS FLOWTM: a nano filled, light cured flowable composite designed to be used with the . QUARTZ SPLINT system for reinforcement and stabilizing of mobile teeth.
Prescription Use X X AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE | |
|---|---|
| ------------------------------------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices |
| 510(k) Number: | K122348 |
|---|---|
| ---------------- | --------- |
Section 4- Page 1 of 1