(115 days)
Not Found
No
The summary describes a physical dental implant abutment and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as an angled abutment, a prosthetic component for dental implants, intended to aid in prosthetic rehabilitation by providing angled correction. It is not described as a device that treats or prevents a disease or condition.
No
The device description states its purpose is for "prosthetic rehabilitation" and "angled correction" in dental restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a physical component (angled abutments) used in dental implant procedures, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is an "Endosseous dental implant angled abutment." These are prosthetic components designed to be surgically implanted and connected to a dental implant within the patient's mouth.
- Intended Use: The intended use is for "prosthetic rehabilitation" in dental restorations, specifically for angled correction. This is a mechanical and structural function within the body, not an analysis of biological specimens.
The device is a medical device, but it falls under the category of a dental prosthetic component, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
K022258, K053355, K062749, K994119
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
§ 872.3630 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.)
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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.
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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
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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.
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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
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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