(130 days)
Not Found
No
The document describes a mechanical dental abutment system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device, the Legacy Abutment System, is intended to provide support for crowns, bridges, or overdentures for dental implants. It is a restorative component, not an active therapeutic device that treats or prevents a disease.
No
The device, the Legacy Abutment System, is intended to provide support for crowns, bridges, or overdentures with dental implants. Its function is structural and prosthetic, not diagnostic. There is no mention of it collecting data or providing any analysis to identify a disease, condition, or information about the health status of a patient.
No
The device description clearly states it consists of "cement retained and screw-retained components," which are physical hardware components, 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 the device is for providing support for dental prosthetics (crowns, bridges, overdentures) on dental implants. This is a mechanical function within the body.
- Device Description: The description details the physical components and their function in connecting to dental implants and supporting prosthetics.
- 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) 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 (within the body) as a structural component for dental restorations.
N/A
Intended Use / Indications for Use
The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients.
The Legacy Abutment System is compatible with implants that have mating diameters, lead-in bevels, internal hex sizes, and 1-72UNF internal threads, as shown in the Zimmer Dental Tapered Screw-Vent Surgical Manual.
Implant Direct LLC will monitor the compatible implants for modifications to ensure future compatibility. In the event of any modification, Implant Direct LLC will either modify the Legacy abutment to ensure compatibility, or cease claiming compatibility to the modified Zimmer Dental Screw-Vent implants.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Legacy Abutment System consists of cement retained and screw-retained components. All abutments have the same identical interface diameters as the predicate abutments to function with the corresponding mating Screw-Vent Implants manufactured by Zimmer Dental. The cement retained abutments are offered in a straight body with a straight or scalloped prosthetic margin and in an angled body with a scalloped prosthetic margin. The screw-retained abutments are offered in different cuff diameters and heights to accommodate for the different implant interfaces and tissue heights.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arches
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.
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
§ 872.3630 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.)
0
Image /page/0/Picture/0 description: The image is a logo for Implant Direct LLC. The logo features a large letter "D" with a dental implant integrated into the left side of the "D". To the right of the "D" is the text "Implant Direct LLC" in a bold, sans-serif font. Below the logo is the website address "www.implantdirect.com".
06 0063
CONFIDENTIAL Legacy Abutment System
K.V. + 0.0006
510(K) SUMMARY
Company Name: Implant Direct LLC Address: 27030 Malibu Hills Road Calabasas Hills CA 91301 Telephone Number: (818) 444-3300 Fax Number: (818) 444-3408 Registration Number: 3001617766 Submitter's Name: Leslie Terry Contact Person: Patty McMahon Date Summary Prepared: January 5, 2006 - amended May 3, 2006
Classification Name: Abutment, Implant, Dental, Endosseous Common/Usual Name: Endosseous dental implant abutment Device Trade Name: Legacy Abutment System
The primary device used for comparison in this summary is the Screw-Vent Dental Implant System (K011028).
1. Description:
The Legacy Abutment System consists of cement retained and screw-retained components. All abutments have the same identical interface diameters as the predicate abutments to function with the corresponding mating Screw-Vent Implants manufactured by Zimmer Dental. The cement retained abutments are offered in a straight body with a straight or scalloped prosthetic margin and in an angled body with a scalloped prosthetic margin. The screw-retained abutments are offered in different cuff diameters and heights to accommodate for the different implant interfaces and tissue heights.
2. Intended Use:
The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients.
The Legacy Abutment System is compatible with implants that have mating diameters, lead-in bevels, internal hex sizes, and 1-72UNF internal threads, as shown in the Zimmer Dental Tapered Screw-Vent Surgical Manual.
Implant Direct LLC will monitor the compatible implants for modifications to ensure future compatibility. In the event of any modification, Implant Direct LLC will either modify the Legacy abutment to ensure compatibility, or cease claiming compatibility to the modified Zimmer Dental Screw-Vent implants.
1
3. Technological Characteristics:
The Legacy abutments provide support for crowns, bridges, or overdentures in edentulous or partially edentulous patients for cement retained and screw retained restorations following the same preparation principals as the predicate devices. The Legacy abutments have similar technological characteristics and the same intended use as the predicate device. The Legacy abutments are packaged non-sterile for sale unlike the predicate devices packaged sterile. The Straight, Scalloped, and Angled Abutments are designed to function as a foundation for cemented restorations. The Screw-Retained abutments are designed to function as a foundation for scrow-retained restoration.
4. Comparison Analysis:
The overall designs of the Legacy Abutment System are similar to the predicate devices. The following Tables 1, 2, 3 summarize the predicate device comparison analyses with the Legacy Abutments.
| Technological
Characteristics | Legacy Straight and Scalloped
Abutments | Predicate Device:
Screw Vent Dental Implant
System (K011028) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Intended Use | To be used as a post to support the
cemented prostheses | To be used as a post to
support the cemented
prostheses |
| Indication | For single or multiple restorations | For single or multiple
restorations |
| General Design | Hex engaging post with a prosthetic
margin | Hex engaging post without a
prosthetic margin |
| Cuff Diameters | 4.5, 5.7, and 6.5 mm | 3.5, 4.5, 5.7, and 6.5 mm |
| Implant/abutment
Interface
diameters | 3.5, 4.5, and 5.7mm | 3.5, 4.5, and 5.7mm |
| Material | Titanium Alloy | Titanium Alloy |
| Packaging | Scalloped Abutments: Screw mount
inside a vial closed with a cap
Straight Abutments:
The abutments are attached to a
plastic transfer/holder engaged within
an inner vial. The inner vial, along
with a screw-mount containing the
temporary coping, will be placed
within a larger outer vial and closed
with a vial cap. | Screw mount inside a vial
closed with a cap |
| Sterilization | Non-sterile | Sterile |
Table 1: Legacy Cement Retained Straight and Scalloped Abutments
2
:
: -
| Technological
Characteristics | Legacy Angled Abutments | Predicate Device:
Screw Vent Dental Implant
System (K011028) |
|----------------------------------|------------------------------------------------------|--------------------------------------------------------------------|
| Intended Use | To be used as a post to support the
prostheses | To be used as a post to
support the prostheses |
| Indication | For single or multiple restorations | For single or multiple
restorations |
| General Design | Hex engaging angled post with a
prosthetic margin | Hex engaging angled post
without prosthetic margin |
| Material | Titanium Alloy | Titanium Alloy |
| Packaging | Screw mount inside a vial closed with
a cap | Screw mount inside a vial
closed with a cap |
| Sterilization | Non-sterile | Sterile |
Table 2: Legacy Cement Retained Angled Abutments
Table 3: Legacy Screw Retained Abutments
| Technological
Characteristics | Legacy Screw-Retained Abutments | Predicate Device:
Screw Vent Dental Implant
System (K011028) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Intended Use | Screw retained restoration | Screw retained restoration |
| Indication | Multiple unit application | Multiple unit application |
| General Design | One-piece abutment that screws inside the implant | One-piece abutment that screws inside the implant |
| Material | Titanium Alloy | Titanium Alloy |
| Packaging | Attached to a plastic transfer/holder engaged within an inner vial. The inner vial, along with a screw-mount containing the temporary coping, will be placed within a larger outer vial and closed with a vial cap | Screw mount inside a vial closed with a cap |
| Sterilization | Non-sterile | Sterile |
5. CONCLUSION
The evaluation of the Legacy Abutment System does not raise any additional concerns regarding safety and effectiveness and therefore is considered substantially equivalent to the predicate device.
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the HHS logo, which is a stylized caduceus. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are written around the top of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 19 2006
Ms. Leslie Terry Implant Direct, LLC 27030 Malibu Hills Road Calabasas Hills, California 91301
Re: K060063
Trade/Device Name: Legacy Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental implant Regulatory Class: II Product Code: NHA Dated: May 3, 2006 Received: May 4, 2006
Dear Ms. Terry:
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.
4
Page 2 - Ms. Terry
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), 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,
Chi-Lien, Ph.D.
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 (if known): K060063
Device Name: Legacy Abutment System
Indications for Use:
The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients.
The Legacy Abutment System is compatible with implants that have mating diameters, lead-in bevels, internal hex sizes, and 1-72UNF internal threads, as shown in the Zimmer Dental Tapered Screw-Vent Surgical Manual.
Implant Direct LLC will monitor the compatible implants for modifications to ensure future compatibility. In the event of any modification, Implant Direct LLC will either modify the Legacy abutment to ensure compatibility, or cease claiming compatibility to the modified Zimmer Dental Screw-Vent implants.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Susan Kunn
Vision Sign-Off
investion of Anesthesiology, Genemaldessives, of CDRH, Office of Device Evaluation (ODE) Infaction Control, Dental Devices
Number: 185600623