Stabilization of mobile teeth Temporary replacement of missing teeth Maintain of inter-dental spaces Maintain of microachar of temporary or permanent bridges

Device Description

Box containing: - 8 ribbons (Braided polyethylene terephtalate fibers) individually wrapped in aluminium bags (width: approximately 2.5 mm - length: approximately 50 mm - thickness: ~ 0,15 mm). - Accessories: BIOSPLINT™ Thermal cutter, BIOSPLINT™ Accessories: brushes and probes -

AI/ML Overview

Acceptance Criteria and Device Performance Study for BIOSPLINT Splinting Ribbons

This document details the acceptance criteria and the studies performed to demonstrate the safety and efficacy of the BIOSPLINT Splinting Ribbons, based on the provided 510(k) summary (K053328).

1. Table of Acceptance Criteria and Reported Device Performance

The BIOSPLINT Splinting Ribbons are a dental device. For such devices, acceptance criteria primarily focus on biocompatibility and mechanical properties (efficacy in its intended use). The efficacy is often established through literature and clinical experience in similar devices, while safety is evaluated through extensive biocompatibility testing.

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria	Reported Device Performance	Study Reference (if applicable)
Efficacy	Professional Literature Validation	Established efficacy of similar devices in professional literature since 1992 (GOLDBERG AJ, BURSTONE CJ, "The use of continuous fiber reinforcement in dentistry" dent.mater 1992; 8:197-202).	"The efficacy of the use of this kind of device is well established in the professional literature since 1992."	Section 7, K053328
	Clinical Use in Europe	Successful use in Europe since 1997.	"The BIOSPLINT™ Splinting ribbon has been successfully used in Europe since 1997."	Section 7, K053328
	Mechanical and Esthetic Properties (Implied)	Mechanical and esthetic properties enable use in recommended clinical situations.	"The mechanical and esthetic properties of these kinds of fibers enhance the use of these products in the recommended clinical situations."	Section 7, K053328
Safety (Biocompatibility)	AMES test (Mutagenicity)	No mutagenic effect.	"has no mutagenic effect against TA-98, TA-1535, TA-1537 and TA-1538 strains without metabolic activation."	Study n° 104E201E
	Pyrogenes test	Comply with French Pharmacopoeia.	"comply"	Study n° 104E201A
	Sensitization test (Guinea Pigs)	Not sensitizing.	"the fibers are not sensitizing."	Study n° 104E201D
	Intramuscular implantation (Rabbit)	Comply with USP XXII.	"comply"	Study n° 104E102
	Toxicity by systemic injection (Mouse)	Comply with USP XXII.	"comply"	Study n° 104E102
	Intradermal injection (Rabbit)	Comply with USP XXII.	"comply"	Study n° 104E102
	Biocompatibility evaluation (Rabbit Implantation)	No local adverse effect (macroscopical and histopathological observation).	"the macroscopical and histopathological observations did not show any local adverse effect which can be due to the fiber."	Study n° 104E203
	In-vitro Cytotoxicity	Not cytotoxic.	"not cytotoxic"	USP XXIII elution test

2. Sample Size Used for the Test Set and Data Provenance

For the safety studies (biocompatibility tests), specific sample sizes are rarely explicitly stated in 510(k) summaries but are implied by adherence to standard regulatory guidelines (e.g., OECD, USP, ASTM, ISO). These guidelines prescribe the number of animals or cells required for each test.

AMES test: The test uses bacterial strains (TA-98, TA-1535, TA-1537, and TA-1538). The "sample size" here refers to the number of bacterial colonies tested, which would be numerous and performed in replicates according to the guideline O.C.D.E.n°471. Data provenance is implied to be laboratory testing internal or contracted by the manufacturer.
Pyrogenes test: Typically performed on rabbits. The French Pharmacopoeia would specify the number of rabbits (usually 3 or more).
Sensitization test on guinea pigs: Conducted on guinea pigs, with ASTM F 619-79 likely dictating the number of animals (e.g., 10-20 for the test group). Data provenance is implied to be laboratory testing.
Intramuscular implantation on the rabbit: Conducted on rabbits, with USP XXII specifying the number of animals for the implantation (e.g., 2-4 rabbits).
Toxicity by systemic injection on the mouse: Conducted on mice, with USP XXII specifying the number of animals (e.g., 5-10 mice per extract type).
Intradermal injection on the rabbit: Conducted on rabbits, with USP XXII specifying the number of animals (e.g., 2-4 rabbits).
Biocompatibility evaluation (Implantation test on the rabbit): Performed on rabbits. The adaptation of ASTM F 763-87, F 981-87, and ISO 10993-6 would specify the number of animals for implantation (e.g., 2-4 rabbits) and the duration of observation (1, 4, 12, 26 and 52 weeks).
In-vitro Cytotoxicity: Performed on cell cultures. USP XXIII would specify the number of cell culture plates/wells used.

Data Provenance: All safety studies are "retrospective" in the sense that they were conducted for the purpose of regulatory submission, likely at contract research organizations. The country of origin for the studies is not explicitly stated, but the submission is from France, and references to French Pharmacopoeia suggest some studies were conducted in France or according to French standards.

For the efficacy claims, the data provenance is primarily from established professional literature and clinical experience in Europe (since 1997), specifically citing French professional literature. This is retrospective observational data. No specific "test set" in terms of a controlled clinical trial with a defined sample size for the BIOSPLINT device is provided for efficacy; rather, the efficacy is established by "substantial equivalence" to predicate devices and general acceptance of the technology.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

For the safety studies, the "ground truth" is established by adherence to recognized international standards and pharmacopoeias (e.g., OECD, USP, ASTM, ISO). The interpretation of results (e.g., histopathological observations, cytotoxicity readings) would be performed by qualified laboratory scientists specialized in toxicology and pathology, following the procedures outlined in these standards. The number of such experts is not specified but is inherent to the execution of such standardized tests.

For efficacy, the ground truth is established through the consensus in professional literature and successful clinical use over time. The "experts" in this context are the authors of the cited articles and the general dental professional community who have adopted and published on this type of technology. Their specific qualifications (e.g., years of experience) are not detailed but are implied by their publication in peer-reviewed journals and academic affiliations (e.g., "G.KOUBI Chairman of university Marseilles France").

4. Adjudication Method

For the safety studies, an explicit "adjudication method" in the sense of multiple independent expert reviews of a single case is not typically described for these types of standardized laboratory tests. The results are based on objective measurements and interpretations by trained laboratory personnel following established protocols. Any discrepancies would be resolved through re-testing or internal quality control procedures.

For efficacy, there is no explicit adjudication method detailed as the evidence is based on published literature and general clinical acceptance rather than a specific test set requiring adjudication.

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

No MRMC comparative effectiveness study was mentioned or performed. This type of study is more common for diagnostic imaging AI devices, where the "reader" is a clinician interpreting images. The BIOSPLINT device is a material used in dentistry, not a diagnostic tool where human interpretation is a primary variable to be assessed for improvement with AI assistance.

6. Standalone Performance Study

No standalone (algorithm only without human-in-the-loop performance) study was done, as this is not an AI-powered diagnostic or therapeutic algorithm. The "device" is a physical material (splinting ribbon).

7. Type of Ground Truth Used

For safety, the ground truth is based on standardized test results and expert pathological/toxicological interpretation against established biological criteria (e.g., no mutagenicity, no sensitization, no local adverse effects).

For efficacy, the ground truth is based on expert consensus from professional literature and positive clinical outcomes data from real-world use over time in Europe. It relies on the documented success of similar dental splinting techniques using fiber reinforcement.

8. Sample Size for the Training Set

Not applicable. The BIOSPLINT Splinting Ribbons are a physical material, not a machine learning model that requires a training set. The efficacy and safety are established through material testing and clinical literature, not AI model training.

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

Not applicable, as there is no training set for this device.

Summary

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Ko 53328

Section III - SMDA Summary of Safety and effectiveness – "510(K) Summary"

1. Submitter Information:

Produits Dentaires Pierre Rolland ZI du Phare, 17 avenue Gustave Eiffel Mérignac Cedex 33708 France Telephone: 011 33 556 34 0607 Fax: 011 33 556 34 9292

Contact person: Steven SALESKY SATELEC c/o Acteon, Inc. 130 Gaither Drive, Suite 100 Mt. Laurel, NJ 08054 Telephone: 856 222-9988 Fax: 856 222-4726

Date summary prepared: November 25th , 2005

2. Device name

Trade Name:	BIOSPLINT Splinting ribbon
Common/Usual Name:	Dental Splinting ribbon
Classification Name:	Dental / Resin, denture, Relining, Repairing, Rebasing, per 21 CFR §872.3760

3. Devices for which Substantial Equivalence is claimed:

RIBBOND (RIBBOND Inc) K913040 dated 10/07/1991 ..
CONNECT (SYBRON DENTAL SPECIALITIES Inc) K954689 dated 10/30/1995 -

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4. Device description:

PRESENTATION

Box containing:

8 ribbons (Braided polyethylene terephtalate fibers) individually wrapped in aluminium bags (width: approximately 2.5 mm - length: approximately 50 mm - thickness: ~ 0,15 mm).
Accessories: BIOSPLINT™ Thermal cutter, BIOSPLINT™ Accessories: brushes and probes -

PROPERTIES

BIOSPLINT™ Splinting ribbons are fixed to the teeth using a light curing flowable hybrid composite and a one-bottle light-curing adhesive system. BIOSPLINT™ Splinting ribbons are treated using the so-called "super-critical fluid" process. This treatment is a process for "cleaning" the fibers, allowing to improve the impregnation of the fiber by the composite and thus to improve the cohesion of the overall tooth retention system

BIOSPLINT™ Splinting ribbons can be pliable in order to the curves of the teeth. Their low thickness makes it possible to avoid any oral embarrassment after setting in place.

BIOSPLINT™ Splinting ribbons can remain in place for several years if necessary; in this case a regular monitoring of the patient is necessary.

Intended use of the Device 5.

BIOSPLINT™ Splinting ribbons are used for Stabilization of mobile teeth, Temporary replacement of missing teeth, Maintain of inter-dental spaces, Reinforcement or repairing of temporary or permanent bridges.

6. Substantial Equivalence:

The BIOSPLINT™ Splinting ribbon is substantially equivalent to other legally marketed devices in the United States: CONNECT and RIBBOND are intended for a similar use.

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Efficacy of the Device 7.

The efficacy of the use of this kind of device is well established in the professional literature since 1992 (GOLDBERG AJ, BURSTONE CJ, "The use of continuous fiber reinforcement in dentistry" dent.mater 1992; 8:197-202).

The BIOSPLINT™ Splinting ribbon has been successfully used in Europe since 1997.

The following articles concerning their efficacy in clinical practice have been published in French professional literature:

«Provisional mandibular contention, : interest of BIOSPLINT - About a clinical case» N.KOUBI and G. ABOUDHARAM - G.KOUBI Chairman of university Marseilles France Information dentaire n° 1 du 5 janvier 2000 p 11-19
«Uses of fibers reinforced composite in dentistry » BIJAOUI J. - SIMON A.L. - TIRLET G. René DESCARTES University PARIS 5 -France Les cahiers de l'ADF N° 10 - 4ème trimestre 2000
« A new material for an esthetic contention : polyethylenephtalate fibers » OUHAYOUN J.P. and BENALIKHOUJA M. University of Garancière PARIS 7 -France Information dentaire n° 9 du 28 février 2001 p 569-578

· «Temporary replacement of unit tooth in implantology: polymere ribbon and flowable composite»

OUHAYOUN J.P. University of Garancière PARIS 7 -France Alternatives n° 26 de mai 2005 p 45-49

The mechanical and esthetic properties of these kinds of fibers enhance the use of these products in the recommended clinical situations. Copies of listed articles are available upon request.

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Safety of the Device 8.

The BIOSPLINT™ Splinting ribbon is controlled according to the specifications presented in Appendix D.

BIOSPLINT™ Splinting ribbon comply to the following tests:

AMES test,

Method: according to guidelines O.C.D.E.n°471 (1981) - EEC 84/449 - annex V - method B14 (1984) ref: studv n° 104E201E

Results and conclusion: According to the experimental conditions described, the flat fibers ref FTEKRU1950 has no mutagenic effect against TA-98, TA-1535, TA-1537 and TA-1538 strains without metabolic activation.

Pyrogenes test,

Method: according to the French Pharmacopoeia - ref: study n ° 104E201A Results and conclusion: comply

Sensitization test on guinea pigs ।

Method: according the method described in the Annual book of ASTM standards F 619-79- ref: study nº 104E201D

Results and conclusion: According to the experimental conditions described (extract prepared at 37 °C during 120 hours with 0.9 % sodium chloride solutions), the fibers are not sensitizing.

Intramuscular implantation on the rabbit, ।

Method: according to USP XXII - ref: study n° 104E102 Results and conclusion: comply

Toxicity by systemic injection on the mouse -

Method: according to USP XXII on extracts prepared at 50°C during 72 hours with 0.9 % sodium chloride solutions, 5 % alcohol solutions, gingili oil and polyethylene glycol 400 solutions. - ref: study n° 104E102

Results and conclusion: comply

Intradermal injection on the rabbit

Results and conclusion: comply

Biocompatibility evaluation

Method: implantation test on the rabbit (adaptation of ASTM F 763-87, F 981-87 and ISO 10993-6) was performed with a semi-quantitative histological study of the tissue response after 1, 4, 12, 26 and 52 weeks - ref: study n° 104E203

Results and conclusion: the macroscopical and histopathological observations did not show any local adverse effect which can be due to the fiber.

in-vitro Cvtotoxicity ।

Method: according to USP XXIII - elution test (incubation 48 hours, 37 °C, 5% CO2) Results and conclusion: not cytotoxic

Test results available upon request.

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2006

SATELEC C/O Mr. Steven Salesky Regulatory Affairs Acteon, Incorporated 130 Gaither Drive, Suite 100 Mount Laurel, New Jersey 08054

Re: K053328

Trade/Device Name: BIOSPLINT Splinting Ribbons Regulation Number: 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 29, 2005 Received: December 1, 2005

Dear Mr. Salesky:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because of the device is substantially equivalent (for the relerenced above and have atternslosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale commerce proces that have been reclassified in accordance with the provisions of Amendinents, or to de result Act (Act) that do not require approval of a premarket the Federal F ood, Drag, and Sobu may, therefore, market the device, subject to the general approvin approvisions of the Act. The general controls provisions of the Act include controls proviblems of an 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 (1 Mr.), it may be subject is the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device to rearly routher announcements concerning your device in the Ecderal Register.

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Page 2 - Mr. Salesky

Please be advised that FDA's issuance of a substantial equivalence determination does not r rease be advisod that I Dri-5 tooming on that your device complies with other requirements moan that I Dri nas made statutes and regulations administered by other Federal agencies. of the Act of any I edetal back's requirements, including, but not limited to: registration 1 ou must comply with art 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF R Part 877), abality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadion 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) I mis feter whilance . Jourse of substantial equivalence of your device to a premarket notified.com. - The PDF 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), n you deather 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 may obtain other generational 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 yours,

Clare

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

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Indication for Use

510(k) Number (if known):

K053328

Device Name:

BIOSPLINT Splinting ribbons

Indications For Use:

Stabilization of mobile teeth Temporary replacement of missing teeth Maintain of inter-dental spaces Maintain of microachar of temporary or permanent bridges

Please refer to the attached file for a complete description.

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

Over-The-Counter Use (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)

Susan Russey

Division (Area 09)
Division of Respiratory, General Hospital,
Infection Control, Dental Devices

1000 | Number

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Regulation Number and Section

§ 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.