(115 days)
Endosseous dental implant angled abutments are premanufactured prosthetic components directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation. They can be used in singled and multi-unit restorations where angled correction is required.
BTI Endosseous dental implant angled abutments consist of 15 degree angled abutments. The artificial tooth abutments are designed to fit and function on the internal and external BTI conexion implants.
They can be used in singled and multi-unit restorations where angled correction is required.
The angled abutments differ from the BTI predicate abutments in that the abutments are angled. The angled abutments provide for more flexibility in the implant placement and restoration process.
The provided text is a 510(k) summary for a medical device (Endosseous dental implant angled abutments). It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics.
Therefore, many of the requested sections about study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness are not applicable or not present in this type of submission.
Here's a breakdown of the information that can be extracted based on the provided text, and where gaps exist:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable.
This 510(k) summary for Endosseous dental implant angled abutments does not present specific quantitative acceptance criteria or performance metrics derived from a study designed to meet such criteria. Instead, it claims "substantial equivalence" in material, design, and function to existing predicate devices.
The basis for clearance is that the device is "as safe and effective as the predicate devices" based on this substantial equivalence claim, rather than a direct performance study against defined thresholds.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable.
No specific test set or data from a performance study is described in this 510(k) summary. The submission relies on demonstrating substantial equivalence to already cleared devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable.
Since no specific test set or performance evaluation is described, there's no mention of experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not Applicable.
Since no specific test set or performance evaluation is described, there's no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No.
An MRMC comparative effectiveness study was not done. The submission is a 510(k) for substantial equivalence of a physical dental implant component, not an AI or diagnostic device that would typically involve a reader study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable.
This device is a physical dental implant component, not an algorithm or AI system. Therefore, a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used
Not Applicable.
Since no specific performance study is discussed, there is no mention of a ground truth being established (e.g., pathology, expert consensus, outcomes data). The "truth" in this context is the comparison to the performance and safety profiles of the predicate devices.
8. The Sample Size for the Training Set
Not Applicable.
This submission pertains to a physical medical device (dental implant abutment), not a machine learning or AI model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable.
As there is no training set mentioned, the establishment of ground truth for it is not applicable.
{0}------------------------------------------------
510 (K) SUMMARY
e of two
JUN 2 1 2007
510 (K) SUMMARY. SAFETY AND EFFECTIVENESS INFORMATION
ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS
SUBMITTER'S NAME. ADDRESS AND TELEPHONE NUMBER:
B.T.I. Biotechnology Institute, S.L. Parque Tecnológico de Álava Leonardo da Vinci, 14 B Miñano (Álava) 01510 Spain PH: 34 945 297030 FAX: 34 945 297031
CONTACT PERSON
Levre Zúñiga Hernando Quality and Regulatory Affairs Pharmacist
SUMARY PREPARATION DATE:
February 2007
ESTABLISHMENT REGISTRATION No: 3004417597
PROPRIETARY NAME:
Endosseous dental implant angled Abutment
COMMON NAME:
Endosseous dental implant abutment
Endosseous dental implant abutment (Sec. 872.3630)
CLASSIFICATION NAME:
PRODUCT CODE:
NHA
DEVICE CLASSIFICATION:
Class II
PREDICATE DEVICE
The modified Endosseous dental implant angled abutments are claimed to be substantially equivalents in material, design, and function to BTI Endosseous dental implant abutments cleared by FDA under 510 (k) K022258 on Sep 11, 2003 and 510 (k) 053355 on Mar 14, 2006 and in function and design to SFB & CFB Angled Abutments cleared by FDA under 510 (K) K062749 on Nov 29, 2006 and SynOcta® Angled Abutments cleared by FDA under 510 (K) K994119 on Mar 17, 2000.
{1}------------------------------------------------
two of two
K670533
DEVICE DESCRIPTION
BTI Endosseous dental implant angled abutments consist of 15 degree angled abutments. The artificial tooth abutments are designed to fit and function on the internal and external BTI conexion implants.
They can be used in singled and multi-unit restorations where angled correction is required.
The angled abutments differ from the BTI predicate abutments in that the abutments are angled. The angled abutments provide for more flexibility in the implant placement and restoration process.
INTENDED USE
Endosseous dental implant angled abutments are premanufactured prosthetic component directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation.
SUBSTANTIAL EQUIVALENCE
The Endosseous dental implant angled abutments are considered to be substantially equivalent to the ease abutments previously cleared under K022258/K053355, K062749 and K994119.
CONCLUSION
The Endosseous dental implant angled abutments are considered to be substantially equivalent in intended use, material and design to the BTI Endosseous dental implant titanium abutments and in intended use and design to SFB & CFB Angled Abutments and SynOcta® Angled Abutments so we can affirm that Endosseous dental angled implant abutments are as safe and effective as the predicate devices
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Leyre Zúñiga Hernando Quality and Regulatory Affairs Pharmacist B.T.I. Biotechnology Institute, S.L. Leonardo Da Vinci, 14B 01510 Miñano (Álava) SPAIN
JUN 2 1 2007
Re: K070533
Trade/Device Name: BTI Endosseous Dental Implant Angled Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 30, 2007 Received: June 7, 2007
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 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}------------------------------------------------
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.
Chiu Lin, Ph.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
{4}------------------------------------------------
TRADITIONAL 510 (K) SUBMISSION Endosseous dental implant angled abutments
Indications for Use
510(k) Number (if known): _______
Device Name: BTI Endosseous dental implant angled abutments
Indications for Use:
Endosseous dental implant angled abutments are premanufactured prosthetic components directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation. They can be used in singled and multi-unit restorations where angled correction is required.
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)
My Red. Mlu for MSR
( Diston Sign-Off) Division of Anesthesiology, Genera Infection Control, Dental D
510(k) Number: K070533
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)