K Number

Device Name

BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)

Manufacturer

BTLOCK SRL

Date Cleared

2008-04-04

(116 days)

Product Code

DZE

Regulation Number

872.3640

Intended Use

BT-Tite Standard (or VSM) It is intended to be used in maxilla or mandible, and for every kind of reconstruction, preferably not immediately loaded. It is intended to be used in a single stage or two stage surgical procedure. BT-Tite One (or CV1) It is intended to be used in maxilla or mandible, for extraction sites and where the implant would be immediately loaded. It is intended to be used in a single stage or two stage surgical procedure. BT-Tite CV2 (or CV2) It is intended to be used in maxilla or mandible. It is indicated in any situation for extraction sites, where the implant would be immediately loaded and where the bone crest is stable. In case of post-extraction sites, it has to be inserted some millimetres under the bone. It is intended to be used in a single stage or two stage surgical procedure.

Device Description

BTLock implant system is composed by a fixture and an abutinent, joined together by a through screw. Main feature of BTLock implant system is an original and patented internal connection (US patent nº 6659700 B2 dated December 9th 2003). This connection has not compatibility with other system. All prosthetic components and accessories are exclusive for BTLock implant system, BTLock implants are threaded, root-form dental implants, intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore chewing function to partially or fully edentulous patients. BTLock implants are machined from titanium and available tapered. The implants may a) have a surface that consists of a titanium oxide layer, i. e. TiUnite implants (BT-Tite Standard Line); b) be coated with hydroxyapatite powder, i. e. HA Coated implants, (HA Coated Standard Linc); or c) Acid-Etched (Acid-Etched Standard Line). BTLock implant lines may differ also for the kind of thread (One or Standard), while keeping always the same kind of connection. All prosthetic components are indecd compatible with same-sized diameter of all lines. BTLock implants may be placed in the oral cavity using cither a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K041661, K051461

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a dental implant system and its intended use, device description, and performance studies. There is no mention of AI or ML technology in the text.

Therapeutic

No
The device, a dental implant system, is intended to support prosthetic devices to restore chewing function, which is a restorative rather than a therapeutic function in the medical sense of treating a disease or disorder.

Diagnostic

The device is a dental implant system used to restore chewing function, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly states that the device is composed of physical components (fixture, abutment, screw) made of titanium, which are implanted into the jaw. This is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided text, 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 Description: The description clearly states that the BTLock implant system is composed of a fixture and an abutment, which are physical components implanted into the maxilla or mandible to support prosthetic devices.
Intended Use: The intended use is to restore chewing function in partially or fully edentulous patients by supporting artificial teeth. This is a surgical and prosthetic procedure, not a diagnostic test performed on a sample.

The device is a dental implant system, which is a type of medical device used in surgical procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

BTLock Implants are indicated for single or multiple tooth replacement, or for use in terminal or intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth.

BT-Tite One (or CV1) It is intended to be used in maxilla or mandible, for extraction sites and where the implant would be immediately loaded. It is intended to be used in a single stage or two stage surgical procedure.

BT-Tite CV2 (or CV2) It is intended to be used in maxilla or mandible. It is indicated in any situation for extraction sites, where the implant would be immediately loaded and where the bone crest is stable. In case of post-extraction sites, it has to be inserted some millimetres under the bone. It is intended to be used in a single stage or two stage surgical procedure.

Product codes (comma separated list FDA assigned to the subject device)

DZE

Device Description

BTLock implants are threaded, root-form dental implants, intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore chewing function to partially or fully edentulous patients.

BTLock implants are machined from titanium and available tapered. The implants may a) have a surface that consists of a titanium oxide layer, i. e. TiUnite implants (BT-Tite Standard Line); b) be coated with hydroxyapatite powder, i. e. HA Coated implants, (HA Coated Standard Linc); or c) Acid-Etched (Acid-Etched Standard Line).

BTLock implant lines may differ also for the kind of thread (One or Standard), while keeping always the same kind of connection. All prosthetic components are indecd compatible with same-sized diameter of all lines.

BTLock implants may be placed in the oral cavity using cither a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper and/or lower jaw, mandible and/or the maxilla

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)

BTLock has carried on both biocompatibility and mechanical testings anda multi-centered clinical study to proove the effectiveness of the devices before commercialisation. Biocompatibility testings include:

Citotoxicity Eluation test
Skin sensitization test
Salmonella typhirium reverse mutation assay
Intramuscular implantation test
Intracutaneous reactivity test
Pyrogenicity test (USP 151)
Sterility (ISO 11737-2)
Systemic toxicity test

Also carried on mechanical testings (by Politconico di Milano, Milan University) and a multi-centered clinical study over its products.

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.

K041661, K051461

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

Regulation Number and Section

§ 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.

Summary

K073458

Image /page/0/Picture/15 description: The image shows a logo with the text "BTL" inside a circular emblem on the left. To the right of the emblem, the text "BTLlook" is displayed, with "BTL" in a larger, bolder font compared to "look". The overall design appears to be a company logo or brand identifier.

Summary

Abbreviated Premarket Notification, BTLock Srl

| Submitter's name:
Address: | BTLock Srl
97/C, Via Madonnetta
Alte Ceccato, Vicenza, I-36041 | APR - 4 2006 |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------|
| Phone:
Fax Number: | +39 0444 492609
+39 0444 497647 | |
| Name of contact person: | Diego La Rosa
BTLock Srl
Phone: +39 0444 492609
Email: info@btlock.com | |
| Date of this summary: | May 30, 2006 | |
| Name of the device:
Trade or Proprietary Name:
Common or Usual Name:
Classification Name: | BTLock Implant System
BTLock Implant System
BTLock Implant System
Endosseous Implant (21 CFR 872.3640) | |

The legally marketed devices to which we are claiming substancial equivalcnce, according 807.92(a)(3), are the following:

Reference#	Device Name	Manufacturer
K041661	NOBEL BIOCARE
ENDOSSEOUS IMPLANTS	NOBEL BIOCARE UAS
K051461	3I OSSEOTITE DENTAL
IMPLANTS	IMPLANT INNOVATIONS INC.

Description of the device

Intended use

K073458

2 d/s

Image /page/1/Picture/2 description: The image shows a logo with the text "BTLlook". To the left of the text is a circular emblem with the letters "BTL" inside. The text "BTLlook" is written in a stylized font, with the letters connected to each other. The logo appears to be for a company or brand named "BTLlook".

As reported in BTLock surgical protocol, while selecting a candidate to implant treatment, some aspects should be carefully considered:

Patient's expecations and motivations .
Patient's general health conditions �
. Oral hygiene

General contraindications:

Low motivation, bad oral hygiene, cronical or tumoral illness, exceeding use of addicting substances, atrophy of maxillary teeth, illness of neuropsychiatric system, bone growth in progress.

Proposed Labelling

BTLock products may feature basically two kinds of labelling, according the need for gamma-ray sterilisation:

1. Assembled Fixtures (fixture plus cover/surgical screw. assembling screws. implant carrier cap, notouch delivery carrier), which require gamma-ray sterilisation and feature a double labelling (A + B). Each packed implant include also an information sheet, specific for BTLock fixtures.
1. Healing screws, which require gamma-ray sterilisation but feature only one labelling (A). It does not require an information sheet.
Other accessories (abutments and instrumentation) does not required gamma-ray sterilisation and rr feature only one labelling. They docs not require information sheet.

BTLock conforms to 93/42/ECC UE Directive for Medical Devices.

1. Labelling for assembled fixtures:

Assembled fixtures feature a double labelling (LABEL A). See attachment I (Labelling),

Information reported are the following:

Product Description .
. Product Codc
Size (diameter, length). Diameter indicated also by colour code. .
Expiry Date
Manufacturing Date ●
. Batch Number
CE Mark ●
Sterile Mark ●
One-time Use Mark .
Mark to indicate to read information sheet .
Details of manufacturing company .

All the same details are reported also on the label of the internal packaging (LABEL B). Label B is smaller than label A, because it must be used by the dentist in order to record the implant used on patient form. Scc attachment I (Labelling).

Each implant is packed with an information sheet in 4 different languages. See information sheet in attachement II (information sheet).

2. Labelling for healing screws.

Healing screw require gamma-ray sterilisation. They feature only one label, exactly as Label A previously described. Scc attachment I (Labelling).

3. Labelling for other accessories.

K073458

3 5/5

Image /page/2/Picture/2 description: The image shows the logo for "BTLock". The logo consists of a circular emblem on the left, followed by the text "BTLock" in a stylized font. The emblem appears to contain the letters "BTC" within it. The text "BTLock" is presented in a way that the letters are interconnected.

Labelling for other accessories, prosthetic included, is simplier than fixtures and healing screws' one, because gamma-ray sterilisation is not nedeed at all (LABEL C). See attachment I (Labelling).

Information reported are the following:

Product Description .
Product Code .
. Size (diameter, length)
Manufacturing Date .
. Batch Number
. CE Mark
. One-time Use Mark
Details of manufacturing company ●

Description of devise design requirements

All details of products are included in their technical drawings. We include as attachment technical drawings for products class II (fixtures + healing screws). Anyway, all technical drawings are available for FDA review. Considering that the 'critical point' are fixtures and that all the techincal drawings are more than 70, we prefer reducing the number of technical drawings to be attachment III (techincal drawings).

Identification of the risk analysis method

BTlock risk management is carried on according standard 14971 UNI CEI EN ISO.

BTLock products' risk are exactly the same of predicate devices, because matcrials used, treatments and general mechanical properties arc substancially equivalent.

Anyway, BTLock has carried on both biocompatibility and mechanical testings anda multi-centered clinical study to proove the effectiveness of the devices before commercialisation. Biocompatibility testings include:

Biocompatibility testings include:

Citotoxicity Eluation test* (attachment IV) .
Skin sensitization test* (attachment IV) .
Salmonella typhirium reverse mutation assay* (attachment IV) 4
� Intramuscular implantation test* (attachment IV)
. Intracutaneous reactivity test (attachment V)
. Pyrogenicity test (USP 151) (attachment VI)
Sterility (ISO 11737-2) (attachment VII) .
Systemic toxicity test (attachment VIII) .

= Those testing were done in 2001 on implants with a different coating (plasma spray). As that surface is basically riskicr than our current surface and the design was the same, we consider those testing valid also for current products. Also note that the name of BTLock was previously FIDELM sas until end of 2002.

Our quality system include a serie of internal and external checks over our products.

Internal checks are described in our quality system handbook and epsecially in our POS (standard operational procedures) documents. If needed we may provide a summary of those documents. External checks are basically trhe followings:

. SEM analysis (attachment IX)
. Bioburden (attachment X)

Also it may be interesting to have a look at our Sterilisations (attachment XI), valid for fixtures and healing screws.

K073458

485

Image /page/3/Picture/2 description: The image shows the logo for BTLook. The logo consists of the letters "BTL" inside of a circle. To the right of the circle, the word "BTLook" is written in a sans-serif font.

Discussion of the device characteristics

We don't see relevant differences with respect to predicate devices. Anyway. BTLock carried on both mechanical testings (by Politconico di Milano, Milan University) adn a multi-centered clinical study over its products.

Please see Mechanical testings (attachment XII) and Clinical Study (attachment XII),

Materials used to produce BTLock System are described as follows:

1. Fixtures (DZE)

Composition of BTLock fixtures may change in accordance to the diameter. All BTLock fixtures (BTCV), BTIVMA, BTIVHA, BTIVSM, etc ... ) are made of pure medical titanium, whose grade is reported in the following list:

Diameter	3.30mm	3.75mm	4.50mm	5.50mm	6.50
Titanium
Grade	IV	IV	II	II	II

The composition of each grade of titanium used is reported in the following list:

Titanium grade IV: (%)
C 0.041	Fe 0.15	O 0.32	N 0.099	H 0.0008	Ti: Bal
Titanium grade II: (%)
C 0.0003	Fe 0.038	O 0.118	N 0.01	H 0.0019	Ti: Bal

See related titanium certificates.

Commercial product codes related to the previous composition:

BTIVA, BTIVMA, BTIVPS, BTIVHA, BTICV1, BTICHA, BTICPS

= Not for Export

2. Prosthetic Components (NHA)

All BTLock prosthetic components, except from fixation screws and castable abutments, are made of titanium alloy (titanium grade V). The following is then the composition:

Titanium grade V: (%)
Al 5.91 V 3.81	C 0.014	Fe 0.16 O 0.11	N 0.006	H 0.0019	Ti: Ba

Manufacturing codes related to the previous description: BTIANL, BTIIPIM, BTITLC, BTIMTL, BTICTLS, BTIMP, BTIPMLS, BTIPMA, BTIPMCR, BTIPML, BTIPMLE, BTIPMLI, BTIPMLIE, BTIPMOC, BTIPMOR, BTIVT, BTIVT, BTIVFC, BTIVPS.

Fixation screws (exccpt from BTIVPS) are instead made of stainless steel. Here the composition: . Steel AISI 316 L

C 0.03	Si 0.60	Mn 1.43	Cr 18.00	Ni 10.00	Mo 2.00	P 0.04
S 0.03	N 0.07

Manufacturing codes related to the following description:

K073458

505

Image /page/4/Picture/2 description: The image shows the logo for BTLock. The logo consists of the letters BTL inside of a circle on the left, and the word "BTLock" on the right. The letters and word are in a bold, sans-serif font.

BTIVPC, BTIVPL.

Castable abutments are made of Plexiglas (polymothyl methacrylatc). Product codes related to the previous description are: BTIMCL, L BTIMCL, BTICSF, BTICTX, BTICMP.

3. Instrumentation (NDP)

Instrumentation may be made either of stainless stell or titanium grade V. This is the composition:

Steel AISI 316 L
C 0.03	Si 0.60	Mn 1.43	Cr 18.00	Ni 10.00	Mo 2.00	P 0.04
S 0.03	N 0.07
Titanium grade V: (%)
Al 5.91 V 3.81	C 0.014	Fe 0.16 O 0.11	N 0.006	H 0.0019	Ti: Bal.

Manufacturing codes related to the previous description are:

BTICITC. BTICVO. BTICVL. BTIMS, BTISL, BTICCBM, BTICCD, BTICCQ, BTICR, BTICDIN, BTIPR, BTIPA, BTIBOX, BTIPRF, BTIFP, BTICV, BTICV, BTICVM, BTICVLM, BTICQM, BTITW, BTIFC, BTIFCA, BTISP, BTIFSV, BTIOSS, BTIES.

For FDA review, we attach titanium certificates (attachment XIV).

About surfaces of fixtures which will be imported to US features only two kind of treatments:

BT-Tite (the same concept of SLA of Straumann or Osseotite of 31). We believe there is not need to 1. proove the effectiveness and the safety of this kind of surface. Anyway we did many biocompatibility and mechanical testings (see attachments I-XIII)
1. HA Coating (attachment XVII)

Page 2 -- Ms. Battilana

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,

Sutte G. Jr., Michael Davis

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

K073458

Indications for Use

510(k) Number: K073458

Device Name: BTLock Implant System: BT Tite CVz (BT-Tite One or CVI; BT-Tite CV2 or CV2), BT-Tite Standard or VSMz (VSMz (VSM, VSM1, etc.)

Indications for Use

Susa Runner Walof

(Division Sign-Off) Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: Y073458

Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

of i

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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.

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).

§ 872.3640 Endosseous dental implant.

Description of the device

Intended use

Proposed Labelling

1. Labelling for assembled fixtures:

2. Labelling for healing screws.

3. Labelling for other accessories.

Description of devise design requirements

Identification of the risk analysis method

Discussion of the device characteristics

1. Fixtures (DZE)

BTIVA*, BTIVMA, BTIVPS*, BTIVHA, BTICV1, BTICHA*, BTICPS*

2. Prosthetic Components (NHA)

3. Instrumentation (NDP)

More relevant documents

Page 2 -- Ms. Battilana

Indications for Use

BTIVA, BTIVMA, BTIVPS, BTIVHA, BTICV1, BTICHA, BTICPS