(86 days)
Not Found
No
The summary describes a material used for reinforcement and repair, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No
The device is described as a material used to reinforce and repair prosthodontic and orthodontic appliances, and to immobilize teeth, but it does not actively treat a disease or condition; rather, it provides structural support.
No
The device is described as a semi-manufactured product made of fibers used to reinforce and repair prosthodontic and orthodontic appliances, and to immobilize teeth. Its intended use is for structural reinforcement and repair, not for detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a "semi-manufactured product made of fibers" and "silanized glass fibers, impregnated with light curing resin," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device as a material used to reinforce and repair dental prosthetics and appliances, and to immobilize teeth. This is a structural and mechanical function within the mouth.
- Device Description: The description confirms it's a material (silanized glass fibers impregnated with resin) used for reinforcement and repair.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of disease or impairment. IVDs are typically used to test blood, urine, tissue, or other bodily fluids or samples.
The device's function is entirely related to the physical structure and support of dental appliances and teeth, not to diagnostic testing.
N/A
Intended Use / Indications for Use
Tender fiber is a semi-manufactured product made of fibers used to reinforce composite and acrylic prosthodontic appliances and to repair or reinforce denture and rethodontic appliances. It can be use as well to immobilize teeth for periodontic or orthodontic treatments.
These products are for use only by trained and experienced dentists and dental technicians and have become well-known in this area of dentistry, therefore they do not require prescription (Per 21 CFR 801 Subpart D)
Product codes (comma separated list FDA assigned to the subject device)
76EBI, EBI
Device Description
Tender Fiber are silanized glass fibers, impregnated with light curing resin used to reinforce prosthodontic appliances and to repair or reinforce denture and orthodontic appliances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained and experienced dentists and dental technicians
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)
Test results indicate that there are no hazards presented with the use of Tender Fiber as compared with the predicate devices. The different technological characteristics of Tender Fiber (practically the same of Everstick, Everstick Perio, Everstick Ortho) compared with Stick and Ribbond does not raise new questions of safety and effectiveness and demonstrates that the device is safe and effective as the predicate devices.
Potential adverse affects and complications common to glass fibers impregnated with a light curing resin include:
- Allergies or hypersensivities
- No adhesion or incomplete adhesion to teeth
- incorrect or incomplete curing
Cytotoxicity tests appears in appendix II.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.
K011788, K030072, K021126, K003333, K913040
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
§ 872.3760 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
JAN 1 2 2007
CONFIDENTIAL
510(k) Summary
Submitter: Mr. Eugenio Miceli, QA Manager, Micerium SpA, Via Marconi, 83, 16030 Avegno (GE), Italy. Phone: 39 0185 7885 880.
- I. Classification Name and Number: Resin, denture, relining, rebasing - 872.3760 (Product Code 76EBI) . Class: II
- II. Common/Usual Name: Fiber reinforcement material
- III. Proprietary Name: Tender Fiber Ortho, Tender Fiber Due, Tender Fiber Quattro.
- IV. Registration No .: Foreign, in process
XI.
- V. Compliance with Performance Standards: "ISO 4049:2000 Dentistry - Polymer - Based Filling, Restorative and Luting materials".
"ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes"
For the Citotoxicity tests: "ISO 10993 -1:2003 -- Evaluation and testing" "ISO 10993 -5:1999--Tests for in vitro citotoxicity" "ISO 10993-12:2002-- Sample preparation and reference materials"
For risk analysis "ISO 14971:2000/Amd 1:2003 - MEDICAL DEVICES - Application of risk management to medical devices."
VI. Premarket Notification truthful and accurate statement
VII. Description of the Device:
Tender Fiber are silanized glass fibers, impregnated with light curing resin used to reinforce prosthodontic appliances and to repair or reinforce denture and orthodontic appliances.
- Labels and Labeling: Draft labels of the Tender Fiber and instructions for use are VIII. provided.
1
CONFIDENTIAL
IX. Substantial Equivalence:
The Tender fiber are substantially equivalent to:
- Everstick by Stick Tech Ltd., 510 (k) no .: K011788 ।
- Everstick Perio by Stick Tech Ltd., 510 (k) no .: K030072 -
- Everstick Ortho by Stick Tech Lid., 510 (k) no .: K021126 ı
- Stick by Stick Tech Ltd., 510(k) no .: K003333 ・
- Ribbond (TM) by Ribbond Inc, 510(k) no .: K913040 ı
-
These products have the same intended use as predicate devices.
-
Technological characteristics: Ribbond an ultra high modulus polyethylene fiber ribbon with no impregnation, while Stick is a polymer pre-impregnated unidirectional continuous glass fiber.
Everstick, Everstick Perio, Everstick Ortho and Tender fiber have the same technological characteristics of Stick but they are also impregnated with light curing resin. Curing is made with help of dental halogen, plasma or LED light systems. The curing process is triggered by initiators, which initiate the polymerization. These initiators are activated by certain wavelengths of the different light systems and are similar or exactly the same in all listed materials.
Test results indicate that there are no hazards presented with the use of Tender Fiber as compared with the predicate devices. The different technological characteristics of Tender Fiber (practically the same of Everstick, Everstick Perio, Everstick Ortho) compared with Stick and Ribbond does not raise new questions of safety and effectiveness and demonstrates that the device is safe and effective as the predicate devices.
IX.1 Risk to Health.
Potential adverse affects and complications common to glass fibers impregnated with a light curing resin include:
- Allergies or hypersensivities
- No adhesion or incomplete adhesion to teeth
- incorrect or incomplete curing
Cytotoxicity tests appears in appendix II.1
- X. Indications for Use.
Tender fiber is a semi-manufactured product made of fibers used to reinforce composite and acrylic prosthodontic appliances and to repair or reinforce denture and orthodontic appliances. It can be use as well to immobilize teeth for periodontal or orthodontic treatments.
(End of Summary)
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services, USA. The seal features the department's emblem, which is a stylized caduceus with a human figure in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the emblem in a circular fashion. The emblem is black and the background is white.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Eugenio Miceli Quality Assurance Manager Micerium S.P.A. Via Marconi 83 Avegno, Italy 16030
JAN 1 2 2007
Re: K063170
Trade/Device Name: Tender Fiber Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: October 12, 2006 Received: October 18, 2006
Dear Mr. Miceli:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Miceli
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Smitte y. Michou m.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CONFIDENTIAL
X. Indications for Use [Separate Page]
510(k) Number: (not assigned) 106 3170
Device Name: Tender Fiber
Indications for Use: Tender fiber is a semi-manufactured product made of fibers used to reinforce composite and acrylic prosthodontic appliances and to repair or reinforce denture and rethodontic appliances. It can be use as well to immobilize teeth for periodontic or orthodontic treatments.
These products are for use only by trained and experienced dentists and dental technicians and have become well-known in this area of dentistry, therefore they do not require prescription (Per 21 CFR 801 Subpart D)
Susan Quarre
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
File: tender fiber_510K.doc
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