(263 days)
Not Found
No
The summary describes a physical dental abutment and its materials, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a prosthetic component that aids in restoring dental function, not a device used for diagnosis, treatment, or prevention of disease.
No
The device is a prosthetic component intended for use as an aid in prosthetic rehabilitation, providing support for a prosthetic restoration. It is not described as gathering or analyzing information for diagnostic purposes.
No
The device description clearly states it is a physical component (titanium abutments) intended for dental implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "premanufactured prosthetic component directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation." This describes a device used in vivo (within the body) for structural support and restoration, not a device used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description further reinforces this by explaining how the abutment is placed into a dental implant to support a prosthetic restoration.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information.
Therefore, the Inclusive® Titanium Abutments for Astra OsseoSpeed™ Implants are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Inclusive® Titanium Abutments for Astra OsseoSpeed™ Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Astra Tech OsseoSpeed™ 3.0, 3.5, 4.0, 4.5, 5.0 implants.
Product codes
NHA
Device Description
Inclusive® Titanium Abutments for- Astra OsseoSpeed™ Implants are endosseous implant abutments which are placed in to the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. These abutments are made of titanium grade Ti-6Al-4V ELI (meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. These abutments are compatible with the Astra OsseoSpeed™ Implants.
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
Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of analysis of platforms to identify worst-case test samples and performance of fatigue testing of the worst-case samples in accordance with the FDA guidance Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the device is safe and effective for its intended use and performs as well or better than the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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DEC 2 8 2010
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
A. SUBMITTER INFORMATION
| Company Name: | Prismatik Dentalcraft, Inc. |
|---|---|
| Company Address: | 4141 Mac Arthur Boulevard |
| Newport Beach, CA 92660 | |
| Company Phone: | (949) 440-2683 |
| Company FAX: | (949) 440-2787 |
| Contact Person: | Kathleen Dragovich, (949) 399-1940 |
| Date Summary Prepared: | December 20, 2010 |
B. DEVICE IDENTIFICATION
| Trade/Proprietary Name: | Inclusive ® Titanium Abutments for- Astra OsseoSpeed ™ |
|---|---|
| Implants | |
| 21 CFR Reference: | 872.3630 |
| 21 CFR Common Name: | Endosseous Dental Implant Abutment |
| Classification: | Class II |
| Panel: | Dental NHA |
C. IDENTIFICATION OF PREDICATE DEVICE
Astra Tech AB OsseoSpeed™ Narrow, K081666 (10-07-08) Trade/Proprietary Name: Astra Tech Implant - Dental System, K990304 (07-15-99) Astra Tech Implant – Dental System, K931767 (02-08-94)
D. DEVICE DESCRIPTION
Inclusive® Titanium Abutments for- Astra OsseoSpeed™ Implants are endosseous implant abutments which are placed in to the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. These abutments are made of titanium grade Ti-6Al-4V ELI (meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. These abutments are compatible with the Astra OsseoSpeed™ Implants.
INDICATIONS FOR USE ن
The Inclusive® Titanium Abutments for Astra OsseoSpeed™ Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Astra Tech OsseoSpeed™ 3.0, 3.5, 4.0, 4.5, 5.0 implants.
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F. SUBSTANTIAL EQUIVALENCE
The Inclusive® Abutments for Astra OsseoSpeed™ Implants are substantially equivalent to the Atlantis™ Abutment for Astra Tech OsseoSpeed 3.0 Implant System, and the Astra Tech Implants Dental System Abutments. These abutments are substantially equivalent in intended use, indications for use, material, design and performance.
| Element of
Comparison | Prismatik's
Inclusive® Abutments for
Astra OsseoSpeed™
Implants | Astra Tech AB
OsseoSpeed™
Narrow, K081666 | Astra Tech Implant –
Dental System,
K990304 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | CP Titanium |
| Platform
Diameters
(mm) | 3.0, 3.5, 4.0, 4.5, 5.0mm | 3.0, 3.5, 4.0, 4.5, 5.0mm | 3.0, 3.5, 4.0, 4.5,
5.0mm |
| Indications | The Inclusive® Titanium
Abutments for Astra
OsseoSpeed™ Implants are
premanufactured prosthetic
components directly
connected to endosseous
dental implants and are
intended for use as an aid in
prosthetic rehabilitation.
They are compatible with the
Astra Tech OsseoSpeed™ 3.0,
3.5, 4.0, 4.5, 5.0 implants. | The Atlantis Abutment is
intended for use with an
endosseous implant to
support a prosthetic device
in a partially or completely
edentulous patient. It is
intended for use to support
single and multiple tooth
prosthesis, in the maxillary
lateral incisors and
mandibular lateral and
central incisors. The
prosthesis can be cement
retained to the abutment.
The abutment screw is
intended to secure the
abutment to the
endosseous implant. The
device is compatible with
the Astra Tech OsseoSpeed
3.0mm Implant | For use in selected fully
edentulous and partially
edentulous arches. |
| Design | implant/Abutment assembly
with abutment screw.
Abutment connection to
implant is an internal
hexagon. | Implant/Abutment
assembly with abutment
screw. Abutment
connection to implant is an
internal hexagon. | Implant/Abutment
assembly with abutment
screw. Abutment
connection to implant is
an internal hexagon. |
| Performance | Fatigue testing conducted by
Straumann® on stock Astra
Tech TiDesign™ abutments
and OsseoSpeed™ implants
showed mean fatigue
strength at 30° was around
110N and 125N for the 3.0
and 2.5mm implant
diameters, respectively. | Fatigue testing conducted
at Engineering Materials
Laboratory on angled
Inclusive® abutments and
Astra Tech OsseoSpeed™
implants showed mean
fatigue strength at 20" was
166.8N and 244.7N for the
3.0 and 3.5mm implant
diameters, respectively.
The higher fatigue strength
results can be attributed to | |
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G. PERFORMANCE DATA
Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of analysis of platforms to identify worst-case test samples and performance of fatigue testing of the worst-case samples in accordance with the FDA guidance Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the device is safe and effective for its intended use and performs as well or better than the predicate device.
H. COMPARISON OF TECHNOLOGICAL DIFFERENCES
There are no known technological differences between the Inclusive® Titanium Abutments for- Astra OsseoSpeed™ Implants and those of the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a human figure embracing a bird, symbolizing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Kathleen Dragovich Regulatory Affairs Specialist Prismatik Dentalcraft, Incorporated 4141 Mac Arthur Boulevard Newport Beach, California 92660
DEC 2 8 2000
Re: K100993
Trade/Device Name: Inclusive® Titanium Abutments for Astra OsseoSpeed™ Implants Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 20, 2010 Received: December 22, 2010
Dear Ms. Dragovich:
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. 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.
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Page 2 - Ms. Dragovich
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 device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,
Anthony Watson, B.S., M.S., M.B.A. 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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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT. INC" on the bottom line.
Prismatik Dentalcraft, Inc. 4141 Mac Arthur Boulevard Newport Beach, CA 92660
INDICATIONS FOR USE STATEMENT
DEC 2 8 2010
510(K) Number: K100993
Device Name: Inclusive® Titanium Abutments for Astra OsseoSpeed™ Implants
Indications for Use:
The Inclusive® Titanium Abutments for Astra OsseoSpeed™ Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Astra Tech OsseoSpeed™ 3.0, 3.5, 4.0, 4.5, 5.0 implants.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.S. Betz, DDS for Dr. Susan Renner
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number: K100993
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