(52 days)
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No
The document describes a mechanical dental abutment and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an accessory to dental implants used to connect prosthetic bridges or crowns, not to treat or diagnose a disease or condition.
No
Explanation: The device, Intra-Lock International Angled Prosthetic Abutments, is an accessory used to connect prosthetic bridges or crowns to dental implants. Its intended use is for "prosthetically restor[ing] Endosseous Implants" and "improv[ing] the aesthetics of the final restoration." This function is restorative and aesthetic, not diagnostic.
No
The device description explicitly states the device is manufactured from Titanium Alloy and is a physical component (abutment) used to connect a prosthetic to a dental implant. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "prosthetically restor[ing] Endosseous Implants" and connecting a "laboratory fabricated prosthetic bridge or crown to the implanted dental implant." This is a surgical/dental device used directly on a patient for structural support and restoration.
- Device Description: The description reinforces this by stating it's an "accessory to the Intra-Lock Endosseous Dental Implants" and performs the function of "connecting" the prosthetic to the implant.
- IVD Definition: An In Vitro Diagnostic device is used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease. This device does not interact with or analyze such specimens.
The information provided describes a medical device used in a dental procedure, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Intra-Lock International Angled Prosthetic Abutments are intended to prosthetically restore Endosseous Implants. These abutments are designed to be used on single tooth applications and or multiple tooth might applications. They are intended to be used when minor correction or alignment will improve the aesthetics of the final restoration.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Intra-Lock International Angled Prosthetic Abutments are an accessory to the Intra-Lock Endosseous Dental Implants. They perform the function of connecting the laboratory fabricated prostheric bridge or crown to the implanted dental implant. They are manufactured from Titanium Alloy (6 Al-4V ELI, ASTM F136) and are provided in a number of sizes to accommodate tissue depth. These prositietic abutments are provided in non-sterile packaging.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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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Image /page/0/Picture/1 description: The image contains a sequence of alphanumeric characters, specifically "K040205". The characters are written in a bold, sans-serif font, and they appear to be handwritten or drawn with a thick marker. The characters are arranged horizontally, with the letter "K" at the beginning and the number "5" at the end.
510(k) Summary
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Intra-Lock International is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Intra-Lock International chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
| Trade Name: | Intra-Lock International Angled Prosthetic Abutments |
|---|---|
| Sponsor: | Intra-Lock International |
| 1200 North Federal Highway, Suite 200 | |
| Boca Raton, FL 33432 | |
| Registration No.:3003631996 | |
| Device Generic Name: | Angled Abutments |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class III. |
Predicate Devices:
| Straumann USA, Angled Abutments | K994119 |
|---|---|
| Opti-Max Angled Crown Post | K972769 |
| Implant Innovations, Pre-Angled Abutments | K932123 |
Product Description:
The Intra-Lock International Angled Prosthetic Abutments are an accessory to the Intra-Lock Endosseous Dental Implants. They perform the function of connecting the laboratory fabricated prostheric bridge or crown to the implanted dental implant. They are manufactured from Titanium Alloy (6 Al-4V ELI, ASTM F136) and are provided in a number of sizes to accommodate tissue depth. These prositietic abutments are provided in non-sterile packaging.
Indications for Use:
Intra-Lock International Angled Prosthetic Abutments are intended to prosthetically restore Endosseous Implants. These abutments are designed to be used on single tooth applications and or multiple tooth bridge applications. They are intended to be used when minor correction or alignment will improve the aesthetics of the final restoration.
. .
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Safety and Performance:
This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstratial Equivalence in Premarket Notifications." In support of this 510(k), Intra-Lock International has provided information to demonstrate conformity with FDA's guidance document entitled: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Intra-Lock Angled Prosthetic Abutments have been shown to be safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
MAR 2 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey Sakoff Director of Operations Intra-Lock International 1200 North Federal Highway, Suite 200 Boca Raton, Florida 33432
Re: K040205
Trade/Device Name: Intra-Lock Angled Prosthetic Abutment Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: January 9, 2004 Received: February 2, 2004
Dear Mr. Sakoff:
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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Page 2 – Ms. Rivkowich
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 (OS) 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 (301) 594-5613. 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/dsma/dsmamain.html
Sincerely vours.
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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Indications for Use
510(k) Number (if known): K040205
Intra-Lock Angled Prosthetic Abutments Device Name:
Indications for Use:
Intra-Lock International Angled Prosthetic Abutments are intended to prosthetically restore Endosseous Implants. These abutments are designed to be used on single tooth applications and or multiple tooth might applications. They are intended to be used when minor correction or alignment will improve the aesthetics of the final restoration.
AND/OR Prescription Use x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swann Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K.012005
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