(141 days)
Not Found
No
The document describes a dental implant system and its intended use, device description, and predicate devices. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is an implant system used for supporting dental restorations, which replaces missing teeth but does not treat a disease or condition.
No
This device is described as an implant system for dental restoration, which involves surgical procedures to replace missing teeth or support dental prosthetics. Its stated purpose is to provide an "artificial root structure" and "support and retention" for dental restorations, rather than to diagnose medical conditions or diseases.
No
The device description clearly states it is a "Spectra Dental Implant System" consisting of "one-piece implants," which are physical hardware components intended for surgical implantation.
Based on the provided text, 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.
- Device Description and Intended Use: The description clearly states that the Spectra Dental Implant System is a physical implant intended for surgical placement in the jawbone to support dental restorations. It is a device that is implanted into the body, not used to test samples from the body.
The text focuses on the surgical procedure, anatomical location (mandibles and maxillae), and the function of the implant in supporting teeth or dentures. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
The Spectra Dental Implant System consists of one-piece implants for single-stage or two-stage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established.
The ScrewDirect 3.0mm implant is indicated for:
-
- An artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
-
- Multiple tooth replacements or denture stabilization.
The Screw Redirect implant is intended for support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of the partially edentulous maxillary jaw. It is indicated for immediate functional loading when four or more implants are splinted together in the endentulous upper or lower jaw.
The Screw Indirect implant is indicated for the support and retention of bar overdentures or as a terminal or intermediary attachment for screw-retained fixed bridgework. It is indicated for immediate functional loading when four or more implants are splinted together in the edentulous upper or lower jaw. This implant model is not indicated for use with abutments, only with a 2mm extender.
- Multiple tooth replacements or denture stabilization.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous mandibles and maxillae, mandibular central and lateral incisors and maxillary lateral incisors, premolar, cuspid, and incisor regions of the partially edentulous maxillary jaw
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): 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.
Tapered Screw-Vent (K013227), Screw-Vent Dental Implant System (K011028), Astra-Tech Implants Dental System Immediate Function (K041492), Nobel Biocare Groovy Implants (K050258), Advent and SwissPlus Dental Implant Systems (K011245), Nobel Biocare Replace One-Piece Implant (K023952), Lifecore PrimaSolo One-Piece Implant System (K050506)
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
§ 872.3640 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
| SEP 2 9 2006 | ||
|---|---|---|
| K061319 | ||
| 510(k) SUMMARY | ||
| Company Name: | Implant Direct LLC | |
| 27030 Malibu Hills Road | ||
| Calabasas Hills CA 91301 | ||
| Phone Number: | 818 444-3300 | |
| Fax Number: | 818 444-3408 | |
| Registration Number: | 3001617766 | |
| Submitter's Name: | Gerald A. Niznick, DMD, MSD | |
| Contact Persons: | Patty McMahon | |
| Date Summary Prepared: | May 10, 2006 | |
| Classification Name: | Implant, Endosseous, Root Form | |
| Regulation Description: | Endosseous Dental Implant | |
| Common/Usual Name: | Endosseous Dental Implant and Abutment | |
| Device Trade Name: | Spectra-System | |
| Predicate Devices: | ||
| The Spectra-System was compared to the following devices previously cleared through a 510(k) Premarket Notification: | ||
| Tapered Screw-Vent (K013227) | ||
| Screw-Vent Dental Implant System (K011028) | ||
| Astra-Tech Implants Dental System Immediate Function (K041492) | ||
| Nobel Biocare Groovy Implants (K050258) | ||
| Advent and SwissPlus Dental Implant Systems (K011245) | ||
| Nobel Biocare Replace One-Piece Implant (K023952) | ||
| Lifecore PrimaSolo One-Piece Implant System (K050506) |
1
escriptio
ん
tended Use
K0613 0(k) Number: Spectra Dental Implant evice Name:
dications for i
tra Dental Implant System onstrator of two-piece implans for single-stage or two-stage or two-stage or two-stage or
es that are internedials a fully edentlus suport for fixed
irect 3.0mm implant is indicated
- icial root structure for single tooth replacement of mandibular central and lateral
tillary lateral incisors.
2
| 2. Multiple tooth replacements or denture stabilization. | K061319 |
|---|---|
| Screw Redirect implant is intended for support and retention of fixed single tooth and fixed partial denture restorations in | |
| premolar, cuspid, and incisor regions of the partially edentulous maxillary jaw. It is indicated for immediate functional | |
| loading when four or more implants are splinted together in the endentulous upper or lower jaw. | |
| Technological Characteristics: | |
| Spectra-System is substantially equivalent to the predicate devices; has comparable technological characteristics, identical | |
| intended use and are similar in terms of material, size, and basic design features. | |
| Comparison Analysis: | |
| The overall implant product designs of the Spectra System are similar to the predicate devices. Tables 1, 2, 3, and 4 in the following | |
| pages summarize the predicate device comparison analyses for the implants within the Spectra-System. |
:
3
KDG
1319
·
| Technological
Characteristics | ScrewPlant and Legacy
Implants | Predicate Device:
Tapered Screw-Vent
(K013227) | Predicate Device:
Astra-Tech Implants
Dental System Immediate
Function
(K041492) | Technological
Characteristics | RePlant Implants | Predicate Device:
Tapered Screw-Vent (K013227) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for surgical
implantation in edentulous
mandibles or maxillae for | Intended for surgical
implantation in edentulous
mandibles or maxillae for | Intended to provide support
for prosthetic constructions
for fully and partially
edentulous arches using one
or two stage surgical
procedures. | Intended Use | Intended for surgical implantation in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary attachment for fixed or removable bridgework, or as a freestanding single tooth replacement. | Intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices for single or multiple unit restorations in splinted or non-splinted applications. |
| | attachment of complete
denture prostheses, or as a
terminal or intermediary
attachment for fixed or
removable bridgework, or as a
freestanding single tooth
replacement. | attachment of complete
denture prostheses, or as a
terminal or intermediary
attachment for fixed or
removable bridgework, or as
a freestanding single tooth
replacement. | | Indication | Immediate Load | Immediate Load |
| Indication | Immediate Load | Immediate Load | Immediate Load | General Design | Threaded, root form implant | Threaded, root form implant |
| General
Design | Threaded, root form implant | Threaded, root form implant | Threaded, root form implant | Placement Method | Two or single stage surgery | Two or single stage surgery |
| Placement
Method | Two or single stage surgery | Two or single stage surgery | Two or single stage surgery | Material | Titanium alloy | CP4 Titanium |
| Material
Implant Body
Type | Titanium alloy
Threaded body with micro-
threads at the collar section | Titanium alloy
Threaded body with smooth
collar | Commercially pure titanium
Threaded body with micro-
threads at the collar section | Implant Body Type | Threaded body with micro-threads at the collar section | Threaded body with groves at the collar section |
| Body Diameter | 3.7mm, 4.7mm, 5.7 mm | 3.7mm, 4.7mm, 6.0mm | 3.5, 4.0 mm | Body Diameter | 3.5mm, 4.3mm, 5.0mm, 6.0mm | 3.5mm, 4.3mm, 5.0mm, 6.0mm |
| Lengths | 8mm – 16mm | 8mm – 16mm | 8mm – 19 mm | Lengths | 8mm – 16mm | 8mm – 16mm |
| Platform
Diameter | ScrewPlant: 3.7, 4.7, 5.7mm
Legacy: 3.5, 4.5, 5.7mm | 3.5, 4.5, 5.7mm | 3.5, 4.0, 4.5, 5.0mm | Platform Diameter | 3.5mm, 4.3mm, 5.0mm, 6.0mm | 3.5mm, 4.3mm, 5.0mm, 6.0mm |
| Implant
Surface | Roughened (HA blasted) or
Roughened (HA blasted) and | HA coated./Roughened or
Roughened - HA Blasted | Micro-roughened surface | Implant Surface | Roughened (HA blasted) | Roughened surface |
| | plasma HA coated | | | Packaging | Inner sleeve to suspend the implant assembled with a plastic carrier or titanium fixture mount inside an outer vial sealed with a cap. Packaging may include surgical cover screw, extender, and coping. | Outer vial and cap |
| Packaging | Inner sleeve to suspend the
implant assembled with a
plastic carrier or titanium | Double vial system. The
implant/fixture-mount
assembly is suspended and
snaps inside the inner vial.
The packaging also offers a
surgical cover screw. | Implants are packaged with
a carrier. | Sterilization | Gamma irradiation | Gamma irradiation |
| Sterilization | fixture mount inside an outer
vial sealed with a cap.
Packaging may include
surgical cover screw,
extender, and coping. | Gamma irradiation | Unknown | | | |
| Gamma irradiation | | | | | | |
:
Table 1: Two-Stage Implants -- ScrewPlant and Legac
4
.
:
:
5
・
.
6
・
| Table 3: One-Stage Implants | | | | Body Diameter | 3.7, 4.7, and 5.7mm | 3.7, 4.7, and 5.7mm | 3.7, 4.7, and 6.0mm | collar section
3.5, and 4.0mm | Technological
Characteristics | Screw Direct
Implants | Screw Redirect
Implants | Predicate Device:
Replace One-Piece
Implant
(K023952) | Predicate Device:
Lifecore PrimaSolo
One-Piece Implant
System (K050506) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| ScrewPlus
Implants | ScrewIndirect
Implants | Predicate Device:
Advent and SwissPlus
Dental Implant
Systems (K011245) | Predicate
Device:
Astra-Tech
Imp.Immediate
Function
(K041492) | Lengths | 8mm – 16mm | 8mm – 16mm | 8mm – 16mm | 8mm – 19 mm | Intended Use | Intended for single
stage surgical
procedures and
cemented restorations. | Intended for single
stage surgical
procedures and
cemented
restorations. | Intended for single
stage surgical
procedure and
cemented
restorations. | Intended for single
stage surgical
procedures and
cement
restorations. |
| Intended for surgical
implantation in
edentulous mandibles
or maxillae for
attachment of complete
denture prostheses, or
as a terminal or
intermediary
attachment for fixed or
removable bridgework,
or as a freestanding
single tooth
replacement. | Intended for surgical
implantation in
edentulous mandibles
or maxillae for
attachment of
complete denture
prostheses, or as a
terminal or
intermediary
attachment for fixed
or removable
bridgework. | Intended for surgical
implantation in
edentulous mandibles
or maxillae for
attachment of complete
denture prostheses, or
as a terminal or
intermediary
attachment for fixed or
removable bridgework,
or as a freestanding
single tooth
replacement. | Intended to
provide support
for prosthetic
constructions
for fully and
partially
edentulous
arches using
one or two stage
surgical
procedures. | Platform Diameter | 3.7, 4.7, 5.7, and 6.5mm | 5.0mm | 4.5 and 5.7mm | 3.5, 4.0, 4.5, 5.0mm | Indication | Immediate Load | Immediate Load | Immediate Load | Immediate Load |
| Immediate Load
Threaded, root form
implant | Immediate Load
Threaded, root form
implant | Immediate Load
Threaded, root form
implant | Immediate Load
Threaded, root
form implant | Implant Surface | Roughened – HA Blasted | Roughened – HA Blasted | HA coated/Roughened or Roughened – HA Blasted | Micro- roughened surface | General
Design | Threaded, root form
implant | Threaded, root form
implant | Threaded, root form
implant | Threaded, root form
implant |
| Single stage surgery | Single stage surgery | Single stage surgery | Two or single
stage surgery | Packaging | Inner sleeve to suspend the implant/fixture- mount assembly inside an outer vial sealed with a cap. Packaging also includes surgical cover screw, extender, and temporary coping | Inner sleeve to suspend the implant/carrier assembly inside an outer vial sealed with a cap. Packaging also includes, extender, and temporary coping | Implants are packaged with a carrier in a double vial system. The packaging also offers a surgical cover screw and an extender. | Implants are packaged with a carrier. | Placement
Method | Single stage surgery | Single stage
surgery | Single stage
surgery | Single stage surgery |
| Titanium alloy | Titanium alloy | Titanium alloy | Commercially
pure titanium | Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation | Unknown | Material | Titanium alloy | Titanium alloy | CPe titanium | Titanium alloy |
| Threaded body with
smooth collar | Threaded body with
smooth collar | Threaded body with
smooth collar | Threaded body
with micro-
threads at the | Implant Body
Type | Tapered threaded body
with an integrated
abutment | Tapered threaded
body with an
integrated angled
abutment | Tapered threaded
body with an
integrated abutment | Tapered threaded
body with an
integrated abutment | | | | | |
| Body Diameter | 3.0, 3.7, 4.7, and
5.7mm | 3.7, 4.7, and 5.7mm | 3.5, 4.3, and 5.0mm | 3.0, 3.5, 4.1, and
5.0mm | | | | | | | | | |
| Lengths | 10, 13, and 16mm | 13 and 16mm | 10, 13, and 16mm | 10mm - 15 mm | | | | | | | | | |
| Implant
Surface | Roughened - HA
Blasted | Roughened - HA
Blasted | HA coated and
roughened surface | Micro-roughened
surface | | | | | | | | | |
| Packaging | Inner sleeve to suspend
the implant/carrier
assembly inside an
outer vial sealed with a
cap. Packaging also | Inner sleeve to
suspend the
implant/carrier
assembly inside an
outer vial sealed | Unknown | Unknown | | | | | | | | | |
7
Kci319
.
. . .
8
K06 1319
.
Table 4: One-Piece Implants
9
| | includes a temporary
coping | with a cap. | | |
|---------------|--------------------------------|-------------------|---------|---------|
| Sterilization | Gamma irradiation | Gamma irradiation | Unknown | Unknown |
Conclusion પતં
Based on the companison analysis, the ident of the market in the more institutios, similar general dosign
features, the Spectra System is substanted to be predicate devices.
A statement that the submitter believes, to the best of his or her knowledge, that all ata and information submitted
ไ
A Truthful and Accurate Statement is included in Section 3.0, signed by Dr. Gerald A. Niznick, the owner of I
Direct L.C.
10
Image /page/10/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human figures, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2006
Ms. Patty McMahon Vice President Implant Direct, LLC 27030 Malibu Hills Road Calabasas Hills, California 91301
Re: K061319
Trade/Device Name: Spectra Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 28, 2006 Reccived: July 31, 2006
Dear Ms. McMahon:
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. Fxisting major regulations affecting vour 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.
11
Page 2 - Ms. McMahon
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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 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/industry/support/index.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
12
Indications for Use
510(k) Number (if known): K061319
Device Name: Spectra Dental Implant System
Indications for Use:
The Spectra Dental Implant System consists of one-piece implants for single-stage or twostage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established.
The ScrewDirect 3.0mm implant is indicated for:
-
- An artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
-
- Multiple tooth replacements or denture stabilization.
The Screw Redirect implant is intended for support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of the partially edentulous maxillary jaw. It is indicated for immediate functional loading when four or more implants are splinted together in the endentulous upper or lower jaw.
The Screw Indirect implant is indicated for the support and retention of bar overdentures or as a terminal or intermediary attachment for screw-retained fixed bridgework. It is indicated for immediate functional loading when four or more implants are splinted together in the edentulous upper or lower jaw. This implant model is not indicated for use with abutments, only with a 2mm extender.
Prescription Use (Part 21 CFR 801 Subpart D)
ASOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOO
AND/OR
Over-The-Counter Use (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)
Robert S. Betz DDS for H. Susan Rummer
Number: K061319