(160 days)
Not Found
No
The summary describes a mechanical dental abutment system and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device's stated purpose is to provide support for prosthetic reconstructions and restore chewing function, which are considered functional and restorative, not explicitly therapeutic in the medical sense of treating a disease or disorder.
No
The device is an abutment for dental implants, used to support prosthetic reconstructions, which is a restorative function, not a diagnostic one.
No
The device description explicitly lists physical components such as abutments, screws, caps, and copings, indicating it is a hardware device, not software-only.
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 abutments are placed into dental implants to support prosthetic reconstructions and restore chewing function. This is a direct interaction with the patient's body for a therapeutic purpose (restoring function).
- Device Description: The description details the physical components of the abutment system, which are mechanical parts designed for implantation and support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device itself is the therapeutic intervention.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is implanted within the body to provide structural support.
N/A
Intended Use / Indications for Use
The Straumann Magellan abutments are indicated to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Magellan abutments are indicated for screw-retained restorations.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
This proposed Magellan™ Bone Level Abutment System is based upon the currently cleared Regular CrossFit® (RC) and Narrow CrossFit® (NC) screw-retained Bar and Bridge Abutment Line under premarket notification K080239. The Magellan product line includes one-piece straight abutments for the NC interface, straight and angled (17° and 30°) abutments for the RC interface, basal screws, occlusal screws, protective caps and titanium and gold restorative copings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance testing of the subject devices was conducted per the FDA guidance Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseious Dental Implants and Endosseous Dental Abutments dated May 12, 2004. Bench testing per ISO 14801 was performed to evaluate the dynamic fatigue performance of the subject devices. No animal or human clinical data was provided in support of this submission.
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.
K990342, K080239, K072071, K101945
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.)
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Traditional 510(k) Submission – Straumann® Magellan™ Abutment System
APR 1 7 2014
| 5. 510(k) Summary - K133421 | |
|---|---|
| SUBMITTER: | Straumann USA, LLC |
| (on behalf of Institut Straumann AG) | |
| 60 Minuteman Road | |
| Andover, MA 01810 | |
| CONTACT PERSON: | Charlotte Ringleb |
| Regulatory Affairs Associate | |
| charlotte.ringleb@straumann.com | |
| 978-.747.2552 | |
| SUBMISSION DATE | November 5, 2013 |
| PRODUCT CODE | NHA (21 CFR §872.3630) |
| DEVICE CLASS | II (21 CFR §872.3630) |
| CLASSIFICATION PANEL | Dental |
| CLASSIFICATION NAME | Endosseous dental implant abutment (21 CFR §872.3630) |
| PROPRIETARY NAME | Straumann Magellan Screw-Retained Abutment System |
| PREDICATE DEVICES | (K990342) Straumann® synOcta screw-retained 1.5 mm |
| Abutment Line | |
| (K080239) Straumann® RC/NC Bar and Bridge Abutment | |
| Line | |
| (K072071) Straumann® Bone Level Cementable Screw | |
| (K101945) Neodent CM Exact Mini Angled Abutment | |
| DEVICE DESCRIPTION | This proposed Magellan™ Bone Level Abutment System is |
| based upon the currently cleared Regular CrossFit® (RC) | |
| and Narrow CrossFit® (NC) screw-retained Bar and Bridge | |
| Abutment Line under premarket notification K080239. | |
| The Magellan product line includes one-piece straight | |
| abutments for the NC interface, straight and angled (17° and | |
| 30°) abutments for the RC interface, basal screws, occlusal | |
| screws, protective caps and titanium and gold restorative | |
| copings. |
. .
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INDICATIONS FOR USE
The Straumann Magellan abutments are indicated to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Magellan abutments are indicated for screw-retained restorations.
TECHNOLOGICAL CHARACTERISTICS
The Straumann Magellan Screw-Retained Abutments, and associated subject devices are manufactured using precision machining systems from solid material (i.e. one-piece construction). Device features faciliate a precise fit with mating features of the previously cleared Straumann Bone Level implants.
| FEATURE | SUBJECT DEVICE
Magellan Screw-
Retained Abutments | PREDICATE DEVICE
Bar & Bridge Abutment
(K080239) | EQUIVALENCE
DISCUSSION |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Implant/Abutment
Connection | CrossFit® connection with
anti-rotation feature | CrossFit® connection
without anti-rotation
feature | Equivalent
Anti-rotation feature not
reqired for bar and bridge
constructs |
| Diameter | The diameters are as noted
for Regular CrossFit (RC)
and Narrow Crossfit (NC):
RC: Ø4.6 mm
NC: Ø3.5, 4.6 mm | The diameters are as noted
for Regular CrossFit (RC)
and Narrow Crossfit (NC):
RC: Ø4.0, 4.5, 6.5 mm
NC: Ø3.5, 4.5 mm | Equivalent
The diameters of the
subject devices are within
the range of the predicate
devices. |
| Gingival Height (GH) | The gingival heights
offered follow:
1.0mm
2.5 mm
4.0 mm | The gingival heights
offered follow:
1.0 mm
2.5 mm
4.0 mm | Equivalent
The gingival heights of the
subject devices are within
the range of the predicate
devices. |
| Abutment Height | The height of the
abutments are as noted:
1.7 mm
1.9 mm | The height of the
abutments are as noted:
1.0 mm
4.6 mm | Equivalent
The abutment heights of
the subject devices are
within the range of the
predicate devices. |
MATERIALS
The Straumann Magellan Screw-Retained Abutments, basal screws and occlusal screws are manufactured from a titanium-aluminium-niobium alloy (Ti-6AI-7Nb or TAN) meeting the requirements of ISO 5832-11. The material for the gold copings is Ceramicor® alloy. The protective caps are produced from polyether ether ketone (PEEK).
2
PERFORMANCE TESTING
Performance testing of the subject devices was conducted per the FDA guidance Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseious Dental Implants and Endosseous Dental Abutments dated May 12, 2004. Bench testing per ISO 14801 was performed to evaluate the dynamic fatigue performance of the subject devices. No animal or human clinical data was provided in support of this submission.
CONCLUSION
The documentation submitted in this premarket notification demonstrates the subject devices and are substantially equivalent to the identified predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2014
Straumann USA, LLC Ms. Charlotte Ringleb Regulatory Affairs Specialist 60 Minuteman Road Andover, MA 01810
Re: K133421
Trade/Device Name: Straumann® Magellan™ Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 14, 2014 Received: March 18, 2014
Dear Ms. Ringleb:
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 addition " . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least of devised that I Dr. o lessan that your device complies with other requirements of the Act that I Dr has Intactions and regulations administered by other Federal agencies. You must or any I cochar salates and registements, including, but not limited to: registration and listing (21
4
Page 2 - Ms. Ringleb
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 (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours,
Erin Keith -S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. Indications for Use
510(k) Number (if known): K | 33401
Straumann® Magellan™ Abutment System Device Name:
Indications for Use:
The Straumann® Magellan™ abutments are indicated to be placed into Straumann® dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Magellan™ abutments are indicated for screw-retained restorations.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Sheena A: Green-S
2014.04.17 15:54:46 -04'00'
Straumann USA, LLC
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