Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a temporary dental abutment made of PMMA and titanium, intended for mechanical support during healing. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The performance studies focus on mechanical strength and fatigue.

Therapeutic

No
The device is a temporary prosthetic component used to support temporary crowns and bridges, maintaining and shaping soft tissue during healing. It is not designed to treat a disease or condition, but rather to aid in a restorative dental process.

Diagnostic

No
The device is described as a temporary prosthetic component used for maintaining, stabilizing, and shaping soft tissue during the healing phase, and as a support structure for temporary crowns and bridges, which are all therapeutic or palliative functions, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly states the device is made of polymethyl methacrylate (PMMA) with a Titanium Alloy (TAN) inlay, indicating it is a physical hardware component, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used in the mouth to support temporary dental restorations and shape soft tissue. This is a direct interaction with the patient's body for a therapeutic purpose (rehabilitation).
Device Description: The device is a physical component (temporary abutment) made of PMMA and titanium alloy, designed to be placed into a dental implant.
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 outside the body to analyze samples and provide diagnostic information. This device is used inside the body for a prosthetic and therapeutic purpose.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Straumann® temporary prosthetic components are indicated to be used prior to the final components to maintain, stabilize, and shape the soft tissue during the healing phase. They must not be placed in occlusion. Strauman® temporary abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of partially edentulous patients with temporary crowns and bridges.

Product codes

NHA

Device Description

Straumann® BLX Temporary Abutments PMMA are temporary abutments intended for placement on Straumann BLX Dental Implants with RB/WB and WB connection platforms. The temporary abutments are made of polymethyl methacrylate (PMMA), with a Titanium Alloy (TAN) inlay.

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

Dynamic fatigue and static strength tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the BLX Temporary Abutments PMMA performed as well as the reference devices.

The subject device materials, PMMA and TAN (titanium alloy), are identical to the reference device materials. The manufacturing processes, packaging, body/fluid contact are identical to the reference devices; therefore, no new issues regarding biocompatibility were raised.

The sterilization validation for the BLX Temporary Abutments PMMA, according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015", was leveraged from K162890.

The conclusion drawn from the nonclinical tests demonstrates that the subject devices, the BLX Temporary Abutments PMMA, are substantially equivalent to the legally marketed primary predicate and reference devices.

Key Metrics

Not Found

Predicate Device(s)

K173961

Reference Device(s)

K122192

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.)

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K220751

Trade/Device Name: Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 11, 2022 Received: March 15, 2022

Dear Jennifer Jackson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)

K220751

Device Name:

Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

Indications for Use (Describe)

Straumann® temporary prosthetic components are indicated to be used prior to the final components to maintain, stabilize, and shape the soft tissue during the healing phase. They must not be placed in occlusion. Strauman® temporary abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of partially edentulous patients with temporary crowns and bridges.

Type of Use (Select one or both, as applicable) 図Prescription Use (Part 21 CFR 801 Subpart D)

□Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

3

Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

510(k) Summary

ട് 510(k) Summary

Submitter's Contact Information 5.1

| Submitter: | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052
On the behalf of:
Institut Straumann AG
Peter Merian-Weg 12
4052 Basel, Switzerland. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs and Quality
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 |
| Prepared By & Alternate Contact: | Viviana Horhoiu
Regulatory Affairs and Compliance manager
Institut Straumann AG
Phone number: +41 61 965 1512 |
| Date of Submission: | May 30, 2022 |

5.2 Name of the Device

| Trade Names: | Straumann® BLX Temporary Abutment, VITA CAD-Temp,
PMMA |
|------------------------|-----------------------------------------------------------|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | §872.3630 |
| Device Classification: | Class II |
| Product Code(s): | NHA |
| Classification Panel: | Dental |

4

Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

510(k) Summary

5.3 Predicate Device(s)

Primary Predicate:

K173961 Straumann® BLX Implant System Institut Straumann AG .
Reference Device:
. K122192 – Straumann Temporary Abutments, PMMA – Institut Straumann AG

Device Description 5.4 -

The subject temporary abutments will be marketed as Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA, however, throughout this 510(k) Summary the subject devices will be referred to as BLX Temporary Abutment, PMMA.

Straumann® BLX Temporary Abutments PMMA are temporary abutments intended for placement on Straumann BLX Dental Implants with RB/WB and WB connection platforms. The temporary abutments are made of polymethyl methacrylate (PMMA), with a Titanium Alloy (TAN) inlay.

5.5 Indications for Use

Straumann® temporary prosthetic components are indicated to be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed in occlusion. Straumann® temporary abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of partially edentulous patients with temporary crowns and bridges.

5

Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

510(k) Summary

5.6 Technological Characteristics

FEATURE	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
K Number		K173961	K122192
Indications
for Use	Straumann® temporary
prosthetic components are
indicated to be used prior to the
insertion of the final components
to maintain, stabilize and shape
the soft tissue during the healing
phase. They must not be placed
in occlusion. Straumann®
temporary abutments are
indicated to be placed into
Straumann® dental implants to
provide a support structure for
the functional and esthetic oral
rehabilitation of partially
edentulous patients with
temporary crowns and bridges.	Straumann® BLX Basal Screws
and Temporary Abutments
Prosthetic components directly or
indirectly connected to the
endosseous dental implant are
intended for use as an aid in
prosthetic rehabilitations.
Temporary components can be
used prior to the insertion of the
final components to maintain,
stabilize, and shape the soft
tissue during the healing phase;
they may not be placed into
occlusion. Final abutments may
be placed into occlusion when the
implant is fully osseointegrated.
BLX Temporary Abutments have
a maximum duration of usage of
180 days.	Straumann® temporary
abutments are indicated to be
placed into Straumann® dental
implants to provide a support
structure for the functional and
esthetic oral rehabilitation of
partially edentulous patients
with temporary crowns and
bridges.	Equivalent
The subject and primary predicate
device indications for use
statements are equivalent. The
subject device does not contain
language regarding final abutments
and the subject device is for
temporary use only.
The type of prosthetic restorations
is implied for the primary predicate
device, but included specifically in
the subject and reference device
indications for use statements.
The statement regarding the
maximum duration of usage has
been moved to the Instructions for
Use for the subject devices.
Material	Titanium alloy/TAN
(Ti-6Al-7Nb),
PMMA	Titanium alloy/TAN
(Ti-6Al-7Nb)	Titanium alloy/TAN
(Ti-6Al-7Nb),
PMMA	Identical
The materials are identical to the
reference device.
Implant to
Abutment
Connection	TorcFit®	TorcFit®	CrossFit®
synOcta	Identical
The connection is identical to the
primary predicate device.
FEATURE	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
K Number		K173961	K122192
Compatibility	RB/WB and WB	RB/WB and WB	Narrow CrossFit® (NC)
Regular CrossFit® (RC)
Narrow Neck CrossFit® (NNC)
Regular Neck (RN)
Wide Neck (WN)	Identical
The compatibility is identical to the
primary predicate device.
Diameter or
Minor Oval
Dimension/
Major Oval
Dimension	Major oval diameter: 10 mm
Minor oval dimensions: 5 mm	RB/WB:
$Ø$ 3.8, $Ø$ 4.5, $Ø$ 6.0
WB:
$Ø$ 5.5	Major oval diameter: 10.1 mm
Minor oval dimensions: 5 mm	Equivalent
The diameters are nearly identical
to the reference devices.
Overall
abutment
length	15.1 and 16.1 mm	13.5, 14.1, 15.1, 16.1, 17.1 mm	16.3 mm	Identical
The overall abutment lengths are
identical to two of the abutment
lengths of the primary predicate
device.
Gingival
heights	1.5 mm	0.75, 1.5, 2.5 and 3.5 mm	1.0 mm	Identical
The gingival height is identical to
one of the gingival heights of the
primary predicate device.
Prosthesis
Fixation	Screw-retained	Screw-retained	Screw-retained	Identical
The prosthetic fixation is identical
to the primary predicate and
reference devices.
Sterilization
Method	Non-sterile	Non-sterile	Non-sterile	Identical
The subject devices are provided
non-sterile and require the same
cleaning, disinfection and
sterilization procedure as the
primary predicate and reference
devices.
FEATURE	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
K Number		K173961	K122192
Duration of
Use	6 months	6 months	6 months	Identical
The duration of use is identical for
the subject, primary predicate, and
reference devices.

6

Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

510(k) Summary

7

Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

510(k) Summary

Table 1 – Comparison of the subject devices with the primary predicate and reference devices

8

Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

510(k) Summary

Performance Testing 5.7 -

Dynamic fatigue and static strength tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the BLX Temporary Abutments PMMA performed as well as the reference devices.

The subject device materials, PMMA and TAN (titanium alloy), are identical to the reference device materials. The manufacturing processes, packaging, body/fluid contact are identical to the reference devices; therefore, no new issues regarding biocompatibility were raised.

The sterilization validation for the BLX Temporary Abutments PMMA, according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015", was leveraged from K162890.

Conclusion 5.8

The conclusion drawn from the nonclinical tests demonstrates that the subject devices, the BLX Temporary Abutments PMMA, are substantially equivalent to the legally marketed primary predicate and reference devices.