(14 days)
No
The device description focuses on the material, dimensions, and intended use of dental implant abutments, with no mention of AI or ML technology.
No.
The device, Thommen SPI® EASY Dental Implant Abutments, is intended to provide support for crowns, bridges, or overdentures, which are restorative functions, not therapeutic.
No
The device description indicates that the Thommen SPI® EASY Dental Implant Abutments are designed to provide support for crowns, bridges, or overdentures in conjunction with dental implants. These are physical components that are placed in the mouth and do not involve the detection, diagnosis, or treatment of a disease or condition through testing or analysis of a sample or image.
No
The device description clearly states the device is made of commercially pure grade titanium and describes physical dimensions and angulation, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for crowns, bridges, or overdentures in the maxillary and/or mandibular arch. This is a structural and mechanical function within the body.
- Device Description: The device is a dental implant abutment made of titanium, designed for cemented restorations. This describes a physical component used in a surgical and restorative procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is implanted within the body to support dental prosthetics.
N/A
Intended Use / Indications for Use
Thommen SPI® EASY Dental Implant Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.
Product codes
NHA, DZE
Device Description
Thommen SPI® EASY Dental Implant Abutments are endosseous dental implant abutments made of commercially pure grade titanium and intended for cemented restorations. They may be used for cemented single crowns or bridges. The existing abutments are offered in four diameterswith lengths from 6.0 mm to 9.0 mm. Straight abutments and abutments with angulation correction of 20° are available. The preangled abutments are also available in the four diameters, with lengths from 6.5 mm to 9.0 mm
The SPI® EASY abutments added by means of this Special 510(k) all are straight abutments and include lengths of 4.3 mm and 7.0 mm in each of the existing diameters. The shorter abutments are intended to reduce or eliminate the need for the clinician to prepare the abutment for restoration.
All SPI® EASY abutments may be used with allSPI® ELEMENT implants (those covered in the HA-Ti predicate device submissions referred to above), as well as withSPI® ONETIME implants, covered by Thommen Medical AG Special 510(k) K022038.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arch
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)
Reference Device(s)
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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KO23645
ADMINISTRATIVE INFORMATION
.
| Manufacturer Name: | Thommen Medical AG
Hauptstrasse 87
CH-4437 Waldenburg
Switzerland
Telephone +41 61 965 90 20
FAX +41 61 965 90 21 | NOV 1 3 2002 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------|
| Official Contact: | Orlando Antunes | |
| Representative/Consultant: | Floyd G. Larson
PaxMed International
4329 Graydon Road | |
San Diego, CA 92130 Telephone (858) 792-1235 FAX (858) 792-1236
DEVICE NAME
| Classification Name: | Abutment, Implant, Dental, Endosseous (NHA) |
|---|---|
| Trade/Proprietary Name: | SPI® EASY Dental Implant Abutment |
| Common Name: | Endosseous Dental Implant Abutment |
ESTABLISHMENT REGISTRATION NUMBER
Thommen Medical AG has submitted an Establishment Registration to FDA. The Establishment Registration number has not yet been assigned. The Owner/Operator number is 9051144.
DEVICE CLASSIFICATION
FDA has classified endosseous dental implants as a Class III device (21 CFR 872.3640). The product code for "Abutment, Implant, Dental, Endosseous" is NHA.
CONFORMANCE WITH PERFORMANCE STANDARDS
No performance standards applicable to endosseous dental implant abutments have been established by FDA. However, the CP titanium Grade 4 used to manufacture Thommen dental implant abutments meets the chemical and mechanical requirements of ASTM F67 and ISO 5832-2.
PREDICATE DEVICE INFORMATION
The predicate device for this modification is the HA-Ti Dental Implant System, cleared by FDA on January 4, 1991 under K901927 and July 12, 2001 under K003045. Thommen Medical AG has acquired the rights to the HA-Ti Dental Implant System from HATI Dental AG and has renamed it the SP18 Dental Implant System.
1
PACKAGING/LABELING/PRODUCT INFORMATION
Thommen SPI® EASY Dental Implant Abutments will be packaged and sold non-sterile. The device is not represented to be "pyrogen free." Samples of product labels are shown in Exhibit II, with copies of the prosthetic procedure manual with the instructions for use. All catalogues will be amended to include the modified devices, consistent with the information shown for existing devices.
INTENDED USE
Thommen SPI® EASY Dental Implant Abutments are intended to be used in conjunction with SP10 System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.
DEVICE DESCRIPTION
Thommen SPI® EASY Dental Implant Abutments are endosseous dental implant abutments made of commercially pure grade titanium and intended for cemented restorations. They may be used for cemented single crowns or bridges. The existing abutments are offered in four diameterswith lengths from 6.0 mm to 9.0 mm. Straight abutments and abutments with angulation correction of 20° are available. The preangled abutments are also available in the four diameters, with lengths from 6.5 mm to 9.0 mm
The SPI® EASY abutments added by means of this Special 510(k) all are straight abutments and include lengths of 4.3 mm and 7.0 mm in each of the existing diameters. The shorter abutments are intended to reduce or eliminate the need for the clinician to prepare the abutment for restoration.
All SPI® EASY abutments may be used with allSPI® ELEMENT implants (those covered in the HA-Ti predicate device submissions referred to above), as well as withSPI® ONETIME implants, covered by Thommen Medical AG Special 510(k) K022038.
EQUIVALENCE TO MARKETED PRODUCT
The modified SP10 EASY Dental Implant Abutment has the following similarities to the predicate SP1® System and HA-Ti Dental Implant Abutments:
- has the same intended use,
- uses the same operating principle, 트
- I incorporates the same basic design,
- . incorporates the same materials, and
- . is packaged and sterilized using the same materials and processes.
In summary, the modified Thommen SPI® EASY Dental Implant Abutment described in this submission is, in our opinion, substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, with three overlapping profiles facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2002
Thommen Medical AG C/O Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130
Re: K023645
Trade/Device Name: SPI® EASY Dental Implant Abutment Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE and NHA Dated: October 28, 2002 Received: October 30, 2002
Dear Mr. Larson:
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 - Mr. Larson
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Patacia Ciccutti for
Timothy A. Ulatowski 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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Special 510(k): Device Modification
SPI® EASY Dental Implant Abutments
Applicant: Thommen Medical AG
510(k) Number: K023645
Device Name: SPI® EASY Dental Implant Abutment
Indications for Use:
Thommen SPI® EASY Dental Implant Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY )
==============================================================================================================================================================================
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
Susan Purpura
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: .