(77 days)
Dental burs are intended to drill bone tissue and provisionally soft tissues during, before and after a surgical intervention of dental implants. Endosseous dental implant abutments are intended to model the gingival tissue during the process of healing after the first or second surgery and to be attached to the implant to hold single or multiple teeth restorations.
Dental bur are rotary cutting devices intended to cut hard structures in the mouth, such as teeth or bone. They are also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices. Endosseous dental implant abutments are premanufactured prosthetic component directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation.
The provided submission for K061383, "TRADITIONAL 510 (K) SUBMISSION BTI Dental Implant System Modification," does not contain information regarding acceptance criteria or a study proving that the device meets such criteria.
The submission is a 510(k) for a modified dental implant system (sterile dental drills kit/abutments and caps). The primary focus of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish specific performance acceptance criteria for a novel device and then prove those criteria are met through a dedicated study.
Here's a breakdown of why this information is absent, based on the provided text:
- Substantial Equivalence Approach: The submission explicitly states, "The modified BTI Dental Implant System is claimed to be substantially equivalent in material, design, and function to BTI Dental Implant System cleared by FDA under 510(k) K022258 on Sep 11, 2003 and 510(k) 053355 on Mar 14, 2006." This indicates that the core approval strategy relies on comparing the new device to existing, already approved devices, rather than establishing de novo performance criteria.
- Lack of Performance Data: The document describes the device, its intended use, and its classification, but it does not present any specific performance metrics (e.g., bone cutting efficiency, abutment stability, wear resistance) that would typically have acceptance criteria. Consequently, there is no study described that would aim to "prove" such criteria were met.
- Focus on Design, Material, and Function: The "CONCLUSION" reiterates: "The modified BTT Dental Implant System is considered to be substantially equivalent in design, material and function to BTI Dental Implant System." This further emphasizes that the evaluation was a comparison of attributes rather than a measurement against new, independent performance benchmarks.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a proving study, as this information is not present in the provided 510(k) submission.
Summary of missing information:
- Table of acceptance criteria and reported device performance: Not provided.
- Sample size for test set and data provenance: Not applicable, as no specific performance test data is presented.
- Number of experts and qualifications for ground truth: Not applicable, as no ground truth establishment for a performance study is described.
- Adjudication method for test set: Not applicable.
- MRMC comparative effectiveness study: Not conducted or reported.
- Standalone (algorithm only) performance study: Not applicable (this is a physical medical device, not an algorithm).
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
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TRADITIONAL 510 (K) SUBMISSION BTI Dental Implant System Modification
510 (K) SUMMARY
510 (K) SUMMARY. SAFETY AND EFFECTIVENESS INFORMATION BTI DENTAL IMPLANT SYSTEM MODIFICATION
| SUBMITTER'S NAME. ADDRESS AND TELEPHONE NUMBER: | B.T.I. Biotechnology Institute, S.L.Parque Tecnológico de ÁlavaLeonardo da Vinci, 14 BMiñano (Álava)01510 SpainPH: 34 945 297030FAX: 34 945 297031 |
|---|---|
| CONTACT PERSON | Leyre Zúñiga HernandoQuality and Regulatory Affairs |
SUMARY PREPARATION DATE:
ESTABLISHMENT REGISTRATION No:
PROPRIETARY NAME:
CLASSIFICATION NAME:
S A
C
Sterile dental drills kit/ Abutments and caps
Dental bur/ Endosseous dental
COMMON NAME:
implant abutment
Pharmacist
March 2006
3004417597
Dental bur (Sec. 872.3240)/ Endosseous dental implant abutment (Sec. 872.3630)
PRODUCT CODE:
EJL/ NHA
DEVICE CLASSIFICATION:
Class I/ II
PREDICATE DEVICE
The modified BTI Dental Implant System is claimed to be substantially equivalent in material, design, and function to BTI Dental Implant System cleared by FDA under 510 (k) K022258 on Sep 11, 2003 and 510 (k) 053355 on Mar 14, 2006.
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TRADITIONAL 510 (K) SUBMISSION BTI Dental Implant System Modification
DEVICE DESCRIPTION
Dental bur are rotary cutting devices intended to cut hard structures in the mouth, such as teeth or bone. They are also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.
Endosseous dental implant abutments are premanufactured prosthetic component directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation.
INTENDED USE
BTI Dental Implant System comprising Endosseous titanium implants and prosthetic elements to be attached to the implants, as well as auxiliary elements for surgical and prosthetic procedures.
The intended use of the system is the restoration of missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.
Intended use for every modified product:
Dental burs are intended to drill bone tissue and provisionally soft tissues during, before and after a surgical intervention of dental implants.
Endosseous dental implant abutments are intended to model the gingival tissue during the process of healing after the first or second surgery and to be attached to the implant to hold single or multiple teeth restorations.
SUBSTANTIAL EQUIVALENCE
The modified Sterile dental drills kit, Abutments and caps are considered to be substantially equivalent to the BTI Dental Implant System.
CONCLUSION
The modified BTT Dental Implant System is considered to be substantially equivalent in design, material and function to BTI Dental Implant System.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2006
Mr. Leyre Zuniga Hernando Quality and Regulatory Affairs B.T.I. Biotechnology Institute, S.L. Parque Tecnologico de Alava Leonardo Da Vinci, 14 B Minano (Alava), Spain 01510
Re: K061383
Trade/Device Name: BTI Sterile Dental Drills Kit/ BTI Abutments and Caps Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA, EJL Dated: April 4, 2006 Received: May 18, 2006
Dear Mr. Hernando:
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 referenced to reastated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device merslate ectime 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 approvisions of the Act. The general controls provisions of the Act include controls provident of w registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wri). It may of caejoes to annot in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or router announcements concerning your device in the Federal Register.
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Page 2 - Mr. Hernando
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 clectronic 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 yours,
Charles
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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TRADITIONAL 510 (K) SUBMISSION BTI Dental Implant System Modification
Indications for Use
510(k) Number (if known): __K061383
Device Name: BTI Sterile dental drills kit/ BTI Abutments and caps
Indications for Use:
Dental burs are intended to drill bone tissue and provisionally soft tissues Dental Dors' are Theendou-crosical intervention of dental implants.
Endosseous dental implant abutments are intended to model the gingival Endosseous dental Implant abutinents are internet second surgery and to be tissue uuring the process of neaking and multiple teeth restorations.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Penner
on Sign-Off) ്ഥാ of Anesthesiology, General Hospital, - Control, Dental Devices
) Number P061353
§ 872.3240 Dental bur.
(a)
Identification. A dental bur is a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. It is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.