(175 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical testing of dental implants and accessories, with no mention of AI or ML.
Yes
The device is a dental implant system intended to replace missing teeth, which serves a therapeutic purpose by restoring function and improving oral health.
No.
The T.A.G. Dental Implant System is intended to replace teeth and is composed of implants and accessories used in dental implantation procedures, which are therapeutic rather than diagnostic.
No
The device description explicitly details physical components made of titanium alloy, stainless steel, and PEEK, which are hardware.
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 dental implant system intended to replace teeth in the jawbone. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details physical implants made of titanium alloy and accessories like healing caps and abutments. These are physical devices used in a surgical context.
- 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 in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a physical implant.
N/A
Intended Use / Indications for Use
The T.A.G. Dental Implant System is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE, NHA
Device Description
The T.A.G.'s Dental Implant System is composed of three sub-families:
(1) Massif - A self-tapping cylindrical screw type implant Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 6 mm not available for diameters below 4.2 mm.
(2) Axis - A self-tapping conical implant. Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 8 mm not available for diameters below 3.75 mm, length 16 mm not available for diameters above 4.2
(3) Crestone - A one piece implant Available in Lengths of 10 - 16 mm and Diameters 3.0 - 3.5 mm.
The implants are provided sterilize for single patient use. Each implant is provided with cover screw inside the sterile package. All implants are made of titanium alloy grade 23 (Ti-6AI-4V-ELI).
Provided are accessories which are used in dental implantation procedures. They are: Superstructures which are Healing Caps & Abutments made from Titanium Alloy TI 6AL 4V ELI, Stainless Steel, and/or PEEK. The superstructures are single patient use to be supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular or maxillary alveolar process
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)
No clinical testing was submitted for this 510(k) notification. Performance testing, which was submitted, was performed at an accredited independent laboratory in accordance with FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff and ISO14801 Static and Cycling Loading Test of Dental Implants. This results of this testing demonstrated that T.A.G. Dental Implant System meets the requirements of the standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 14, 2015
T.A.G Medical Products Corporation, Ltd. c/o Mr. George J. Hattub MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K143326
Trade/Device Name: T.A.G. Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant and Abutments Regulatory Class: II Product Code: DZE, NHA Dated: January 28, 2015 Received: February 4, 2015
Dear Mr. Hattub:
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.
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K143326
Device Name: T.A.G. Dental Implant System
Indications For Use: The T.A.G. Dental Implant System is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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)
Page 1 of 1
3
510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
-
- (a) Submitter George J. Hattub Address: MedicSense, USA 291 Hillside Avenue Somerset, MA 02726 www.medicsense.com 1. (b) Manufacturer T.A.G. Medical Products Address: D. N. Ashrat Kibbutz Gaaton 25130, Israel Mfq. Phone: Tel.: 972-3-647-4840 Contact Person: Erez Adiv Date: May 6, 2015 2. Device & Endosseous Dental Implant & Abutments- class II device (product codes: Classification DZE & NHA). 21 CFR 872.3640 T.A.G. Dental Implant System Name: MIS Dental Implant System (K040807), AB Dental Implants and Accessories 3. Predicate Devices: (K112440) & MIS UNO Narrow Implant System (K092555) 4. The T.A.G.'s Dental Implant System is composed of three sub-families: Description: (1) Massif - A self-tapping cylindrical screw type implant Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 6 mm not available for diameters below 4.2 mm. (2) Axis - A self-tapping conical implant. Available in lengths: 8 - 16 mm and diameters: 3.75 - 6.0 mm Note: length 8 mm not available for diameters below 3.75 mm, length 16 mm not available for diameters above 4.2 (3) Crestone - A one piece implant Available in Lengths of 10 - 16 mm and Diameters 3.0 - 3.5 mm. The implants are provided sterilize for single patient use. Each implant is provided with cover screw inside the sterile package. All implants are made of titanium alloy grade 23 (Ti-6AI-4V-ELI).
4
| Provided are accessories which are used in dental implantation procedures. | |
|---|---|
| They are: | |
| Superstructures which are Healing Caps & Abutments made from Titanium | |
| Alloy TI 6AL 4V ELI, Stainless Steel, and/or PEEK. The superstructures are | |
| single patient use to be supplied non-sterile. | |
| 5. Intended Use: | The T.A.G. Dental Implant System is intended to replace single or multiple |
| teeth in the fully or partially edentulous mandibular or maxillary alveolar | |
| process. The implants are appropriate for immediate loading when good | |
| primary stability is achieved and with appropriate occlusal loading. | |
| 6. Comparison of | |
| Technological | |
| Characteristics: | With respect to its indication for use, the T.A.G. Dental Implant System is |
| substantially equivalent to its predicate devices in that it intended for the | |
| same clinical purpose. With respect to technology, the design is similar as | |
| confirmed by comparison, and the performance is the same as verified by | |
| validation. Based upon this, T.A.G. Medical Products believes that its device | |
| is substantially equivalent to its predicate devices. |
Please see comparison table on next page.
5
| Feature | T.A.G.
"Massif" | AB Dental "I2" Screw
Type Implant | T.A.G.
"Axis" | MIS Dental
Implants
"SEVEN" | T.A.G.
"Crestone" | MIS UNO Dental Implants |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The T.A.G.
Dental
Implant
System is
intended to
replace single
or multiple
teeth in the
fully or
partially
edentulous
mandibular or
maxillary
alveolar
process. The
implants are
appropriate
for immediate
loading when
good primary
stability is
achieved and
with
appropriate
occlusal
loading. | AB Dental Implants are
intended for surgical
placement in the
maxillary and/or the
mandibular arch to
support crowns,
bridges, or overdentures
in edentulous or partially
edentulous patients.
17 Integral Implant, 15
Conical Implant, P15
Temporary Abutment,
P12-T, L Temporary
Flat Connection
Abutment and P 16
Straight Adapter are
appropriate for
immediate loading when
good primary stability is
achieved and with
appropriate occlusal
loading. | The T.A.G.
Dental Implant
System is
intended to
replace single
or multiple
teeth in the
fully or
partially
edentulous
mandibularor
maxillary
alveolar
process. The
implants are
appropriate for
immediate
loading when
good primary
stability is
achieved and
with
appropriate
occlusal
loading. | MIS dental
implants are
intended to be
surgically
placed inthe
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. | The T.A.G.
Dental Implant
System is
intendedto
replace single
or multiple
teeth in the
fully or partially
edentulous
mandibularor
maxillary
alveolar
process. The
implants are
appropriate for
immediate
loading when
good primary
stability is
achieved and
with
appropriate
occlusal
loading | The UNO Narrow Implant is
indicated for use in surgical and
restorative applications for
placement in the mandibular
central, lateral incisor and
maxillary lateral incisor regions
of partially edentulous jaws
where the horizontal space is
limited by adjacent teeth and
roots, to provide support for
prosthetic devices such as
artificial teeth, in order to restore
the patient chewing function.
Mandibular central and lateral
incisors must be splinted if using
two or more 3.0 mm implants
adjacent to one another. The
UNO Narrow Implant is
indicated for immediate
implantation in extraction sites
or implantation in partially
healed or completely healed
alveolar ridge situations. When a
one stage surgical procedure is
applied, the implant may be
immediately loaded when good
primary stability is achieved and
the functional load is
appropriate. |
| Implant Material | Ti6AL4V ELI | same | same | same | same | same |
| Implant
Dimensions | Dia. 3.75-6mm
L=8-16mm | Dia. 3.3-6mm
L=6-16mm | Dia. 3.3-6mm
L=8-16mm | Dia. 3.3-6mm
L=6-16mm | Dia. 3.0-3.5mm
L=10-16mm | Dia. 3.0-3.5mm
L=10-16 mm |
| Implant Surface | Sand
blasting/
acid etching | Sand blasting/
acid etching | Sand blasting/
acid etching | Sand blasting/
acid etching | Sand blasting/
acid etching | Sand blasting/
acid etching |
| Implant Design
Shape | Cylinder
screw | Cylinder screw | Conical screw | Conical screw | One-piece | One Piece |
| Feature | T.A.G.
"Massif" | AB Dental "I2" Screw
Type Implant | T.A.G.
"Axis" | MIS Dental
Implants
" SEVEN" | T.A.G.
"Crestone" | MIS UNO Dental Implants |
|-------------------------|--------------------|--------------------------------------|------------------|------------------------------------|----------------------|-------------------------|
| Sterility of
Implant | Gamma | Gamma | Gamma | Gamma | Gamma | Gamma |
| Feature | T.A.G.
"Massif" | AB Dental "I2" Screw
Type Implant | T.A.G.
"Axis" | MIS Dental
Implants
"SEVEN" | T.A.G.
"Crestone" | MIS UNO Dental Implants |
|--------------------------|-------------------------------------------------|--------------------------------------|------------------|-----------------------------------|----------------------|-------------------------|
| Abutment
Design | Straight and
up to 25
degrees | Straight and up to 25
degrees | same | Straight and up
to 20 degrees | NA | NA |
| Abutment
Material | Stainless
Steel,
Titanium,
and/or PEEK | Titanium and/or Plastic | same | Titanium and/or
Plastic | NA | NA |
| Abutment
Length | 4-8 mm | 1-9 mm | same | 1-9 mm | NA | NA |
| Sterility of
Abutment | Non sterile | Non sterile | Non sterile | Non sterile | NA | NA |
| 510(k) # | pending | K112440 | pending | K040807 | pending | K092555 |
6
-
- Discussion of No clinical testing was submitted for this 510(k) notification. Performance Testing Submitted: testing, which was submitted, was performed at an accredited independent laboratory in accordance with FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff and ISO14801 Static and Cycling Loading Test of Dental Implants. This results of this testing demonstrated that T.A.G. Dental Implant System meets the requirements of the standards.