(254 days)
Not Found
No
The summary describes physical dental implant abutments and their materials, with no mention of software, algorithms, or AI/ML capabilities.
No
Explanation: The device, Biodenta Dental Implant System Abutments, is intended for terminal or intermediate abutment support for fixed or removable crown or bridgework. This is a structural component of a dental implant system, not a device that provides therapy or treatment for a disease or condition. While it aids in the restoration of dental function, it does not fit the common definition of a therapeutic device which typically involves active treatment, prevention, or diagnosis of a medical condition.
No
The device description indicates that the Biodenta Dental Implant System Abutments are components for fixed or removable crown or bridgework, serving as terminal or intermediate support. They are physical parts used in reconstructive dentistry rather than for identifying or diagnosing a condition.
No
The device description explicitly states that the device includes physical components (abutments made of PEEK plastic and Titanium Alloy) and is part of an integrated system of endosseous dental implants, abutments, and prosthetic parts. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "terminal or intermediate abutment support for fixed or removable crown or bridgework." This describes a device used in vivo (within the body) to support dental prosthetics.
- Device Description: The description details the materials and function of dental implant abutments, which are physical components placed in the mouth.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided clearly indicates this is a dental implant component used in a surgical and prosthetic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
Biodenta Dental Implant System Abutments are intended for terminal or intermediate abutment support for fixed or removable crown or bridgework.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Biodenta Dental Implant System Abutments is an extension and compatible to the Biodenta Dental Implant System Bone Level (K111003) which is an integrated system of endosseous dental implants, abutments and prosthetic parts and related surgical instruments.
The Biodenta Dental Implant System Abutments includes 3 abutment types:
Temporary PEEK abutments are manufactured of biocompatible PEEK plastic and used for temporary restorations for 180 days or less. They are attached to the dental implant using an abutment screw made of titanium alloy.
Swift Abutments are manufactured of biocompatible Titanium Alloy. The Abutments are attached to the implant by screwing them directly to the implant with the integrated screw thread. The Swift Abutments are designed in order that crowns and bridges can be attached by cement retention.
Sleeve Abutments are manufactured of biocompatible Titanium Alloy. The Abutments are attached to the implant by screwing them directly to the implant with the integrated screw thread. The Sleeve abutments are designed in order that bridges can be attached by screw retention.
All Abutments are straight abutments.
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)
Non-clinical Testing Data:
The Biodenta Dental Implant System Abutments do not include angled abutments. Following the quide "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseus Dental Implant Abutment" (May 12, 2004) no further fatigue test was performed.
A sterilization validation according to ISO 14937:2009 and a residual moisture validation was carried out to confirm the recommended sterilization parameters and drying time.
Biocompatible raw materials have been used for manufacturing the abutments. The final products have been investigated on the chemical cleanness by an XPS analysis and on leachable cytotoxic substances (according to ISO 10993-5:2009) to determine the effects of the manufacturing process to the materials. The results demonstrate that the final products after manufacturing are considered to be biocompatible.
A risk analysis following the guide "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseus Dental Implant Abutment" (May 12, 2004) has been carried out. The implemented mitigations measures were found being suitable to reduce the residual risks to an acceptable level.
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.
K111003, K053099, K092377, K090234
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.)
0
Image /page/0/Picture/0 description: The image shows the word "biodenta" in a bold, sans-serif font, with the registered trademark symbol to the right of the word. Above the word is a curved graphic element that resembles a crescent shape. At the top of the image is the text "K127559" which appears to be handwritten.
5
510(k) Summary
:
| Owner's name: | Biodenta Swiss AG |
|---|---|
| Address: | Tramstrasse 16 |
| 9442 Berneck | |
| Switzerland | |
| Phone: | +41 71 747 11 11 |
| Fax number: | +41 71 747 11 12 |
| Contact person: | Mr. David Eiler, Regulatory Manager |
| Date summary prepared: | March 18, 2013 |
| Trade / proprietary name: | Biodenta Dental Implant System - Abutments |
| Common name: | Endosseous dental implant abutment |
| Device classification name: | Abutment, Implant, Dental, Endosseous |
| Product code: | NHA |
| Regulation number: | 21 CFR 872.3630 |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ﺍﺳﺖ ﺩﺭ ﻣﺤﻤﺪ ﺍﺳﺖ. ﺩﺭ ﺳﺎﺯﯼ ﺍﺳﺖ. . . . . . . . . . . . . . . . . . . . . . . . . . Legally marketed device to which equivalence is claimed (predicate device):
Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Abutments
5 - 510(k) Summary
| 1. Company: | Biodenta Swiss AG |
|---|---|
| Device name: | Biodenta Dental Implant System - Bone Level |
| 510(k) number: | K111003 |
| 2. Company: | Biohorizons Implant Systems, Inc. |
| Device name: | Biohorizons Plastic Temporary Abutments |
| 510(k) number: | K053099 |
Revision 3.0 5
1 of 4 Section Section page
1
Image /page/1/Picture/1 description: The image shows the word "biodenta" in a bold, sans-serif font. Above the word is a stylized graphic of three curved lines, stacked on top of each other. To the right of the word is a circled R symbol, indicating that the word is a registered trademark.
| 3. Company: | Zimmer Dental Inc. |
|---|---|
| Device name: | Plastic Temporary Abutments |
| 510(k) number: | K092377 |
| 4. Company: | Implant Direct LLC. |
| Device name: | Spectra System Dental Implants 2008 |
| 510(k) number: | K090234 |
Indications for Use:
Biodenta Dental Implant System Abutments are intended for terminal or intermediate abutment support for fixed or removable crown or bridgework.
Device Description:
The Biodenta Dental Implant System Abutments is an extension and compatible to the Biodenta Dental Implant System Bone Level (K111003) which is an integrated system of endosseous dental implants, abutments and prosthetic parts and related surgical instruments.
The Biodenta Dental Implant System Abutments includes 3 abutment types:
Temporary PEEK abutments are manufactured of biocompatible PEEK plastic and used for temporary restorations for 180 days or less. They are attached to the dental implant using an abutment screw made of titanium alloy.
Swift Abutments are manufactured of biocompatible Titanium Alloy. The Abutments are attached to the implant by screwing them directly to the implant with the integrated screw thread. The Swift Abutments are designed in order that crowns and bridges can be attached by cement retention.
Sleeve Abutments are manufactured of biocompatible Titanium Alloy. The Abutments are attached to the implant by screwing them directly to the implant with the integrated screw thread. The Sleeve abutments are designed in order that bridges can be attached by screw retention.
All Abutments are straight abutments.
Non-clinical Testing Data:
The Biodenta Dental Implant System Abutments do not include angled abutments. Following the quide "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseus Dental Implant Abutment" (May 12, 2004) no further fatigue test was performed.
2
Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Abutments 5 - 510(k) Summary
Image /page/2/Picture/1 description: The image shows the logo for "biodenta". The logo consists of the word "biodenta" in a sans-serif font, with a registered trademark symbol to the right of the word. Above the word is a graphic of three curved lines, stacked on top of each other.
A sterilization validation according to ISO 14937:2009 and a residual moisture validation was carried out to confirm the recommended sterilization parameters and drying time.
Biocompatible raw materials have been used for manufacturing the abutments. The final products have been investigated on the chemical cleanness by an XPS analysis and on leachable cytotoxic substances (according to ISO 10993-5:2009) to determine the effects of the manufacturing process to the materials. The results demonstrate that the final products after manufacturing are considered to be biocompatible.
A risk analysis following the guide "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseus Dental Implant Abutment" (May 12, 2004) has been carried out. The implemented mitigations measures were found being suitable to reduce the residual risks to an acceptable level.
Equivalence to marketed device:
Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Dental Implant System Abutments is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design.
The summary table for the Substantial Equivalence Comparison to predicate devices is attached on the following page
3
Premarket Notification / 510(k) Submission
Biodenta Dental Implant System – Abutments
5 - 510(k) Summary
and the contraction of the comments of the comments of the
Image /page/3/Picture/1 description: The image shows the logo for "biodenta". The logo consists of the word "biodenta" in a bold, sans-serif font, with a registered trademark symbol to the right of the word. Above the word is a stylized graphic of three curved lines, stacked on top of each other.
| Subject Device | Predicate Devices | ||||
|---|---|---|---|---|---|
| Device Name | Biodenta Dental Implant | ||||
| System - Abutments | Biodenta Dental Implant | ||||
| System - Bone Level | |||||
| K111003 | Biohorizons Plastic | ||||
| Temporary Abutments | |||||
| K053099 | Zimmer Dental Inc. | ||||
| Plastic Temporary Abutments | |||||
| K092377 | Implant Direct LLC. | ||||
| Spectra System Dental Implants 2008 | |||||
| K090234 | |||||
| Intended Use | |||||
| Intended use | Biodenta Dental Implant | ||||
| System Abutments are | |||||
| intended for terminal or | |||||
| intermediate abutment | |||||
| support for fixed or | |||||
| removable crown or | |||||
| bridgework | Biodenta bone level dental | ||||
| implants are intended for | |||||
| surgical placement in | |||||
| mandibles or maxillae to | |||||
| support single or multiple | |||||
| tooth restorations or | |||||
| terminal or intermediate | |||||
| abutment support for fixed | |||||
| or removable bridgework | |||||
| and to retain overdentures. | BioHorizons Plastic | ||||
| Temporary Abutments are | |||||
| intended for short-term use | |||||
| of 30 days or less as a | |||||
| base for cemented or | |||||
| screw-retained crown and | |||||
| bridge restoration of dental | |||||
| implants, while esthetically | |||||
| contouring soft tissue. | The Plastic Temporary Abutment is | ||||
| intended to be used to fabricate | |||||
| andsupport provisional restorations that | |||||
| aid increating an esthetic emergence | |||||
| through the gingiva during the healing | |||||
| period and prior to final restoration. The | |||||
| Plastic Temporary Abutment can be used | |||||
| for cement-retained or screw-retained | |||||
| provisional restoration. The abutments | |||||
| can be used for single-unit and multi-unit | |||||
| restorations. Use of the Plastic Temporary | |||||
| Abutment is not to exceed one-hundred | |||||
| and eighty (180) days. | The Spectra-System Dental Implant 2008 | ||||
| system is comprised of dental implant fixtures | |||||
| and prosthetic devices that compose a two- | |||||
| piece implant system. The Dental Implants are | |||||
| intended for use in the mandible and maxilla, | |||||
| in support of single unit or multiple unit cement | |||||
| or screw-receiving restorations and for the | |||||
| retention and support of overdentures. The | |||||
| implants are intended for immediate placement | |||||
| and function for the support of single-tooth or | |||||
| multiple-tooth restorations, recognizing bone | |||||
| stability and appropriate occusal load | |||||
| requirements. | |||||
| Basic Design | |||||
| Abutment Type | Temporary & Final | ||||
| Abutments | Temporary & Final | ||||
| Abutments | Temporary Abutments | Temporary Abutments | Final Abutments | ||
| Abutment as | |||||
| Impression Post | Yes | No | No | No | Yes (fixture mount used as impression |
| post and abutment) | |||||
| Abutment Type | Straight | ||||
| Abutments | Straight & Angled | ||||
| Abutment | Straight | ||||
| Abutment | Straight & Angled | ||||
| Abutment | Straight Abutments | ||||
| Abutment Angle | 0° | 0°-15° | 0° | 0°-17° | 0° |
| Implant / Abut. | |||||
| Connection | Internal Hexagon | Internal Hexagon | Internal Octagon | Internal Hexagon | Internal Hexagon |
| Temporary | |||||
| Abutment Diameter | 4.0 mm | ||||
| 6.5 mm | 3.5 mm | ||||
| 3.7 mm | 3.5 mm | ||||
| 4.5 mm | |||||
| 5.5 mm | |||||
| 6.5 mm | 4.5 mm | ||||
| 5.5 mm | |||||
| 6.5 mm | -- | ||||
| Temporary | |||||
| Abutment Height | 9.8 mm | 7.0 mm | 10.5 mm | 8.0 mm | -- |
| Final | |||||
| Abutment Diameter | 3.7 - 5.5 mm | 3.5 - 6.0 mm | -- | -- | 4.8 - 6.6 mm |
| Final | |||||
| Abutment Height | 1.5 - 12 mm | 5.7 - 9.8 mm | -- | -- | 6.5 mm |
| Material | |||||
| Temporary Ab. | |||||
| Material | biocompatible PEEK | Titanium Alloy | biocompatible PEEK | biocompatible PEEK | -- |
| Terminal | |||||
| Ab. Material | Titanium Alloy | Titanium Alloy | -- | -- | Titanium Alloy |
| Sterilization | Provided Non-Sterile | Provided Non-Sterile | Provided Non-Sterile | Provided Non-Sterile | Provided sterile with implant packaging |
| Reuse | Single use | Single use | Single use | Single use | Single use |
evision 3.
Section 5.
Revision
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2013
Mr. David Eiler Regulatory Manager Biodenta Swiss AG Tramstrasse 16 Berneck, Switzerland 9442
Re: K122559
Trade/Device Name: Biodenta Dental Implant System Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 30, 2013 Received: May 1, 2013
Dear Mr. Eiler:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Kwame O. Ulmer-S
2013.05.03 11:27:36 -04'00'
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
6
Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Abutments 4 - Indications for Use Statement
Image /page/6/Picture/1 description: The image shows the word "biodenta" in a bold, sans-serif font. Above the word is a stylized graphic that appears to be a curved shape with textured details. To the right of the word "biodenta" is a circled R symbol, indicating that the word is a registered trademark.
Indications for Use
510(k) Number (if known):
Device Name: Biodenta Dental Implant System Abutments
Indications for Use:
Biodenta Dental Implant System Abutments are intended for terminal or intermediate abutment support for fixed or removable crown or bridgework.
///22559
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner, DDS, MA
Digitally signed by Mary S. Runner -5
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People, cn=Mary
S. Runner
0.9.2342.19200300.100.1.1-130008795
Date: 2013.05.02 11:39:22 -04'00
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K122559 |
|---|---|
| ---------------- | --------- |
| Page 1 of 1 | |
|---|---|
| -- | ------------- |
| Revision 1.0 | |
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| Section 4 | |
| Section page 2 of 5 |