(78 days)
Not Found
No
The device description focuses solely on the physical components, materials, and design features of dental implants and abutments. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No.
The device is described as a dental implant system intended to provide support for crowns, bridges or overdentures, which is a restorative and supportive function, not a therapeutic one that treats a disease or condition.
No
The device, a dental implant system, is intended for surgical placement to provide support for crowns, bridges, or overdentures. Its described function is structural and mechanical, not for detecting, monitoring, or predicting diseases or health conditions.
No
The device description explicitly details physical components made of titanium, titanium alloys, and gold alloy, such as implants and abutments, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- TITAN Dental Implant System Function: The description clearly states the TITAN Dental Implant System is intended to be surgically placed in the bone to support dental prosthetics. This is a device that is implanted inside the body.
The intended use and device description focus on the physical placement and function of the implant within the patient's body, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
The TITAN Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch and to provide support for crowns, bridges or overdentures.
Product codes
DZE, NHA
Device Description
The TITAN Dental Implant System is comprised of 26 root-form solid screw-type implant designs and a broad range of abutment designs, all of which are based on existing dental implant systems that are cleared for marketing in the United States. Implant design features include external shapes that are cylindrical (15 designs), tapered (10 designs) and stepped (1 design). Both transgingival and submerged designs are included. External implant thread forms include V, square and buttress designs. Anti-rotational features include external and internal design elements. All implants are made from titanium or titanium alloys conforming to ASTM and ISO standards. Surfaces include as-machined surfaces, grit blasted and acid etched surfaces, surfaces treated with resorbable blast media (RBM) and surfaces coated with plasma-sprayed titanium (TPS) or hydroxyapatite (HA). Diameters range from 3.25 mm to 6.5 mm, and lengths from 5.0 mm to 20.0 mm.
Abutment designs include long and short conical abutments, stepped abutments, gold cylinder abutments, gold/plastic castable abutments and ball head abutments. Antirotational features include external and internal design elements. All abutments are made from titanium or titanium alloys conforming to ASTM and ISO standards or from gold alloy. Surfaces include as-machined surfaces and surfaces treated with titanium nittide. Platform diameters range from 3.25 mm to 6.5 mm.
Abutment screws appropriate to each implant/abutment combination, healing abutments, temporary abutments and laboratory components are included in the TITAN Dental Implant System.
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)
K031632, K033430, K972029, K994037, K010185, K972313, K010458, K994376, K021318, K032140, K040714, K002037, K964220, K980439, K030007, K931767
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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TITAN Dental Implant System
04297/
Page
JAN | 4 2005
ADMINISTRATIVE INFORMATION
.
| Manufacturer Name: | Titan Implants, Inc.
18 Columbia Ave.
Bergenfield , NJ 07621
Telephone (201) 439-0027
Fax (201) 439-1145 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Cyril Chen |
| 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: | Implant, Dental, Endosseous (DZE)
Abutment, Implant, Dental, Endosseous (NHA) |
| Trade/Proprietary Name: | TITAN Dental Implant System |
| Common Name: | Endosseous Dental Implant
Endosseous Dental Implant Abutment |
ESTABLISHMENT REGISTRATION NUMBER
The Establishment Registration number for Titan Implants, Inc. is 2249649. The Owner/Operator number is 9041410.
DEVICE CLASSIFICATION
FDA has classified endosseous dental implants as Class II devices (21 CFR 872.3640 according to revision 69 FR 26307, May 12, 2004). The product code for "Implant, Dental, Endosseous" is DZE. Endosseous dental implant abutments are Class II devices (21 CFR 872.3630). The product code for "Abutment, Implant, Dental, Endosseous" is (NHA). Endosseous dental implants and abutments are reviewed by the Dental Products Panel.
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Page 2
INTENDED USE
The TITAN Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch and to provide support for crowns, bridges or overdentures.
DEVICE DESCRIPTION
Design Characteristics
The TITAN Dental Implant System is comprised of 26 root-form solid screw-type implant designs and a broad range of abutment designs, all of which are based on existing dental implant systems that are cleared for marketing in the United States. Implant design features include external shapes that are cylindrical (15 designs), tapered (10 designs) and stepped (1 design). Both transgingival and submerged designs are included. External implant thread forms include V, square and buttress designs. Anti-rotational features include external and internal design elements. All implants are made from titanium or titanium alloys conforming to ASTM and ISO standards. Surfaces include as-machined surfaces, grit blasted and acid etched surfaces, surfaces treated with resorbable blast media (RBM) and surfaces coated with plasma-sprayed titanium (TPS) or hydroxyapatite (HA). Diameters range from 3.25 mm to 6.5 mm, and lengths from 5.0 mm to 20.0 mm..
Abutment designs include long and short conical abutments, stepped abutments, gold cylinder abutments, gold/plastic castable abutments and ball head abutments. Antirotational features include external and internal design elements. All abutments are made from titanium or titanium alloys conforming to ASTM and ISO standards or from gold alloy. Surfaces include as-machined surfaces and surfaces treated with titanium nittide. Platform diameters range from 3.25 mm to 6.5 mm.
Abutment screws appropriate to each implant/abutment combination, healing abutments, temporary abutments and laboratory components are included in the TITAN Dental Implant System.
Material Composition
The implants, abutments and accessories for the TITAN Dental Implant System are made from CP titanium Grades 2 & 4 conforming to ASTM F67 and ISO 5832-2, Ti-6Al-4V ELI alloy conforming to ASTM F136 and ISO 5832-3 or Ti-13Nb-13Zr alloy conforming to ASTM F1713. The surface of the threaded portion of the TITAN dental implants is one of the following: as-machined, grit blasted and acid etched, treated with resorbable blast media (RBM), coated with plasma-sprayed titanium or coated with plasma-sprayed hydroxyapatite (HA). Collar portions are smooth machined. The abutment surfaces are as-machined or coated with titanium nitride. In addition, one design of abutment screw is surface treated using the Tiodize process.
2
TITAN Dental Implant System
EQUIVALENCE TO MARKETED PRODUCT
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For the purposes of FDA's regulation of medical devices, the TITAN Dental Implant System is substantially equivalent in indications and design principles to the following predicate devices:
- Implant Innovations Osseotite Implants cleared on September 16, 2003 under K031632 .
- Implant Innovations TG Osseotite Implants cleared November 7, 2003 under K033430 .
- Bicon Dental Implant II cleared August 18, 1997 under K972029 .
- Bicon Dental Implant II 4.5 mm cleared January 11, 2000 under K994037 .
- Bicon Dental Implant II 6.0 x 5.7 mm cleared December 30, 2002 under K010185 .
- BioHorizons Maestro Dental Implant cleared September 16, 1997 under K972313 .
- BioHorizons Maestro Dental Implant cleared May 16, 2001 under K010458 .
- Frialit-2 Dental Implant cleared March 24, 2000 under K994376 ●
- Friadent XiVE Dental Implant cleared July 2, 2002 under K021318 .
- INNOVA Endopore Dental Implant cleared October 2, 2003 under K032140 .
- INNOVA Endopore Dental Implant April 9, 2004 under K040714 .
- Lifecore Dental Implant cleared May 16, 2001 under K002037 .
- SteriOss (now Nobel Biocare) Replace Tapered Implant cleared March 5, 1997 . under K964220
- SteriOss (now Nobel Biocare) Replace Cylindrical Implant cleared March 16, . 1998 under K980439
- Straumann ITI Dental Implant System cleared March 31, 2003 under K030007 .
- Astra Tech Dental Implant System cleared February 8, 1994 under K931767. .
The TITAN Dental Implant System has the following similarities to the predicate devices:
- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same basic design,
- · incorporates the same materials, and
- · is packaged and sterilized using the same or equivalent materials and processes.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of the usual one.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2005
Titan Implants, Incorporated C/O Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130
Re: K042971
Trade/Device Name: TITAN Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: October 25, 2004 Received: October 28, 2004
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 the Fouchar F 600; Drag). You may, therefore, market the device, subject to the general approvial upprivious 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 (1111), it ancan 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 Eederal Register.
4
Page 2 - Mr. Larson
Please be advised that FDA's issuance of a substantial equivalence determination does not I Tease be advisod that I Dr. determination that your device complies with other requirements mount that 127 may made statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements, including, but not limited to: registration 1 od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 ce read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quarty ijon 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) This letter will anon you to began finding of substantial equivalence of your device to a premaired 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), 11 you deente 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 may overn 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,
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
5
Indications for Use
510(k) Number: K042971
Device Name: TITAN Dental Implant System
Indications for Use:
The TITAN Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch and to provide support for crowns, bridges or overdentures.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Re Muly for MSP
(Division Sign-Off) Division of Anesthesiology, Generai Hospital Infection Control, Dental Device
510(k) Number: K042971
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