(135 days)
Not Found
No
The summary describes a purely mechanical dental device component and contains no mention of AI, ML, or related concepts like image processing, data sets, or performance metrics associated with algorithmic analysis.
No.
The device itself is a component in a dental restoration system, an adapter bushing that allows for the seating of an abutment to an implant. While it contributes to restoring patient esthetics and chewing function, this is its secondary effect as part of a larger system. The device's primary function as described is mechanical adaptation, not directly therapeutic action on the body.
No
The device is described as an adapter for dental implants, designed to restore patient aesthetics and chewing function. There is no mention of it being used to diagnose a condition or disease.
No
The device description clearly states it is a "hollow titanium alloy device," indicating it is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Nobel Biocare NOBELREPLACE® Adapter is a physical component used in dental restorations. It is a bushing that connects a smaller abutment to a larger implant within the patient's mouth.
- Lack of Diagnostic Activity: The device does not perform any tests on biological samples to diagnose or detect anything. Its function is purely mechanical and structural within the dental restoration process.
Therefore, the description clearly indicates a medical device used for treatment and restoration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Nobel Biocare's NOBELREPLACE® Adapter is a bushing that enables seating of a smaller diameter abutment to a larger diameter endosseous implant-supported dental restoration of a partially or fully edentulous jaw in order to restore patient esthetics and chewing function.
Product codes
NHA
Device Description
Nobel Biocare's NOBELREPLACE® Adapter is a hollow titanium alloy device intended for use as an accessory component designed to adapt a smaller platform abutment to a larger platform endosseous implant to a within the implant/abutment system.
The NOBELREPLACE® Adapter provides a gradual transition from abutment to implant, and can only be used as part of the implant/abutment system, not on its own. It is designed to remain a component of the implant/abutment system for as long as the implant remains in the patient's mouth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
• Oral Cavity
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.)
0
Koso444
JUL 7 - 2005
510(k) Summary of Safety and Effectiveness 1.4
| Submitted by: | Elizabeth J. Mason
Sr. Regulatory Affairs Specialist |
|----------------------------------------|-----------------------------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 7830 |
| Facsimile: | (714) 282-9023 |
| Date of Submission: | February 18, 2005 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary
or Model Name: | NOBELREPLACE® Adapter |
| Legally Marketed Device(s): | Replace Scalloped Margin Implant System (K021584)
Nobel Biocare Permanent Centric Post (K040573) |
Device Description:
Nobel Biocare's NOBELREPLACE® Adapter is a hollow titanium alloy device intended for use as an accessory component designed to adapt a smaller platform abutment to a larger platform endosseous implant to a within the implant/abutment system.
The NOBELREPLACE® Adapter provides a gradual transition from abutment to implant, and can only be used as part of the implant/abutment system, not on its own. It is designed to remain a component of the implant/abutment system for as long as the implant remains in the patient's mouth.
Indications for Use:
Nobel Biocare's NOBELREPLACE® Adapter is a bushing that enables seating of a smaller diameter abutment to a larger diameter endosseous implant-supported dental restoration of a partially or fully edentulous jaw in order to restore patient esthetics and chewing function.
Nobel Biocare Traditional 510(k) Notification NOBELREPLACE® Adapter February 2005
000008
1
Legally Marketed Device Information 2.4
The legally marketed equivalent devices are listed below:
| Predicate Device: | Replace Scalloped Margin Implant System |
|---|---|
| Predicate 510(k): | K021584 |
| Company: | Nobel Biocare |
| Predicate Device: | Nobel Biocare Permanent Centric Post |
| Predicate 510(k): | K040573 |
| Company: | Nobel Biocare |
A comparison of the attributes and intended use of the candidate device, NOBELREPLACE® A ocmpanoen of the atthe predicate device is provided in Section 2.5.
.
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| Section 2.5 | Substantial Equivalence Comparison to Predicate Devices | ||
|---|---|---|---|
| ATTRIBUTE | CANDIDATE | PREDICATE | PREDICATE |
| NOBELREPLACE® Adapter | Replace Scalloped Margin Implant System | ||
| (K021584) | Nobel Biocare Permanent Centric Post | ||
| (K040573) | |||
| Anatomical Site | • Oral Cavity | • Oral Cavity | • Oral Cavity |
| Abutment | |||
| Diameter | • 5.0 mm | • 3.5mm | |
| • 4.3mm | |||
| • 5.0mm | • 3.5mm | ||
| • 4.3mm | |||
| • 5.0mm | |||
| Implant-Supported | |||
| Device | • Yes | • Yes | • Yes |
| Raw Material | • Titanium Vanadium Alloy | • Titanium Vanadium Alloy (abutments) | • Santoprene |
| Intended Use | • Permanent | • Permanent | • Permanent |
| Load-Bearing | |||
| Member of | |||
| Implant/Abutment | |||
| System | • Yes | • Yes | • No |
| Sterility | • Sterile | • Sterile (endosseous implants) | • Non-Sterile |
| Indications for Use | Nobel Biocare's NOBELREPLACE® | ||
| Adapter is a bushing that enables seating | |||
| of a smaller diameter abutment to a larger | |||
| diameter endosseous implant in an | |||
| implant-supported dental restoration of a | |||
| partially or fully edentulous jaw in order to | |||
| restore patient esthetics and chewing | |||
| function. | The Replace Scalloped Margin Implant System | ||
| is an implant with a scalloped coronal margin, | |||
| designed for single stage or two stage surgical | |||
| procedures. The Replace Scalloped Margin | |||
| Implant System is intended for use to restore | |||
| chewing function in edentulous and/or partially | |||
| edentulous patients. | The Nobel Biocare Permanent Centric Post is a | ||
| support component indicated for use as both an | |||
| alignment post to center an abutment, and as a | |||
| seal to prohibit fluids from seeping into the | |||
| implant interior. The Nobel Biocare Permanent | |||
| Centric Post is a component within the implant | |||
| system, and is intended for use in permanent | |||
| restorations in order to restore the chewing | |||
| function of fully edentulous and/or partially | |||
| edentulous patients. |
Nobel Biocare Traditional 510(k) Notification
NOBELREPLACE® Adapter
February 2005
3
Image /page/3/Picture/1 description: The image shows the seal for the Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 7 - 2005
Mr. Herbert Crane Director of Regulatory Affairs Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K050444
Trade/Device Name: NOBELREPLACE® Adapter Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 9, 2005 Received: June 10, 2005
Dear Mr. Crane:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section Pre (--) fre device is substantially equivalent (for the relerenced above and have determined ure) to legally marketed predicate devices marketed in indications for use stated in the checked of the enactment date of the Medical Device interstate comments, or to that been reclassified in accordance with the provisions of Amendinents, of to devroes mat nave oose (Act) that do not require approval of a premarket the Federal FUOG, Drug, and Oosmette 110 (reso) , market the devices, subject to the general approval appreadon (1 Mr.). - 1 ou - any - roa - and - see include controls provisions of the rious and group of devices, good manufacturing practice, requirements for aibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into existing major regulations affecting (PMA), it may be subject to such acantenar connections, Title 21, Parts 800 to 898. In the Coderol your device can be found in the ecas nouncements concerning your device in the Federal Register.
4
Page 2 - Mr. Crane
Please be advised that FDA's issuance of a substantial equivalence d.stermination does not Please be advisod that I Dr. 3 issualled on that your device complies with other requirements mean that I DA nas made a deceminations administered by other Federal agencies. of the Act of ally I ederal butter and regirements, including, but not limited to: registration 1 ou must comply with an the Here's reg (21 CFR Part 801); good manufacturing practice and ifsung (21 CFR Part 067), laceling systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality brovisions (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) I his letter will anow you to begin mailering your substantial equivalence of your device to a premarket notheation. The FDF intents 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), II you desire specific advice for your do roll be 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 obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Birman (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
5
Indications for Use
510(k) Number (if known): |{οδοΥΨΥ
Device Name: NOBELREPLACE® Adapter
Indications For Use:
Nobel Biocare's NOBELREPLACE® Adapter is a bushing that enables seating of a smaller Nobel Bloodie 3 NOBEET endosseous implant in an implant in an implant-supported dental diameter abutinent to a farger atantilous jaw in order to restore patient esthetics and
chewing function.
Prescription Use × (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)
Kein Muly for KSR
(Division Sign-Off)
(Division of Anesthesiology, Geoeral Hospit (Division Sign-C Division of Anesthous Control, Dental
Infection Control, Dental 510(k) Number
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