BT-Tite CV3: It is intended to be used in maxilla or mandible, for post-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.

Mini Implant: It is intended to be used in maxilla or mandible for immediate and long-term stabilization of removable prosthesis.

Mini Single: It is intended to be used in maxilla or mandible in anterior narrow sites of dental arch, to replace lateral teeth, dental agenesis and inferior incisors.

Slot implant: It is intended to be used as temporary intra-oral anchorage unit in the orthodontic treatment in the superior or inferior arch or extra arch in case of edentulous patients, when necessary teeth for the anchorage are absent or the next teeth are compromised from a parodontal point of view. It facilitates the orthodontic movement of teeth. It is removed after orthodontic treatment has been completed. Slot implants are intended for single use only.

Device Description

BTLock implant are 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. The main feature of BTLock implant system is an original and patented connection (US patent n° 6659700 B2 dated December 9th 2003, attachment nº 11). This connection has no compatibility with other systems. All prosthetic components and accessories are exclusive for BTLock implant system. It included BT-Tite CV2 and BT-Tite Standard lines which have been approved by the FDA with the 510(K) number 073458.

BT-Tite CV3 is an implant line which includes fixture and abutment joined together by a through screw. CV3 fixture is machined from titanium, with a deep thread, micro-grooves on the collar, 6 longitudinal long grooves along the body till the collar, DMA surface and a platform designed for the platform-switching. The surface treatment called DMA (which stands for doppia mordenzatura acida, that is double acid-etching) is obtained by the combination of sand-blasting and double acid-etching. This treatment is absolutely equivalent to BT-Tite (no material is added, no changes in the material used for the treatment: just acid-etching is performed twice instead than once).

This line features a conical-cylindrical shape as the other fixtures of BTLock system. Therefore, because of this equivalence, I submitted the same tests carried for the other lines (BT-Tite One, BT-Tite CV2, BT-Tite Standard).

It is available in 3 diameters (3,75 - 4,5 - 5,5 mm) and 5 lengths (8 - 10 - 11,5 - 13 -16 mm). The technical details of the product are included in its own drawing (see attachment nº 18).

Mini Implant: The fixture of the mini implant line is machined from titanium and self-threading. They are available in 3 diameters (2 - 2,5 - 3 mm) and 3 lengths (11,5 - 13 - 16 mm). The implant length includes the machine-cut collar (1,5 mm) and the threaded part which features a surface treatment called BT-Tite, which is obtained by the combination of sand-blasting and acid-etching.

Mini Single: It is a self-threaded and tapered implant made of titanium alloy. The fixture's body features BT-Tite as surface treatment (already approved by FDA, see K073458). This implant has a one-piece design, that is the abutment is integrated to the implant, and an anatomic design. The implant and the abutment are made of the same material.

It is available in 2 diameters (2,5 - 3 mm) and 4 lengths (10 - 11,5 - 13 - 16 mm).

Slot Implant: This device is made of titanium alloy, has a tapered and self-tapping shape. The head has 2 slots, one hole and one neck. The neck is polished (in order not to interfere with soft tissue). It can be loaded immediately.Its smooth threaded surface allows easy removal at the end of treatmet: as a matter of fact because complete osteointegration is neither expected nor desired with this anchorage system because its utilization is temporary.

It is available in 2 diameters (1,6 - 2 mm) and 3 lengths (6 - 7,5 - 9 mm).

AI/ML Overview

The BTLock dental implants (BT-Tite CV3, Mini Implant, Mini Single, Slot Implant) were approved through the 510(k) pathway, which establishes substantial equivalence to legally marketed predicate devices rather than proving device performance against specific acceptance criteria in a standalone study. Therefore, the information typically requested regarding acceptance criteria and performance studies in the context of an AI/ML device is not directly applicable to this submission.

However, based on the provided document, here's an attempt to extract relevant information that might loosely align with your request, focusing on the studies conducted to support the safety and effectiveness for substantial equivalence:

Summary of Information from K083869 for BTLock Dental Implants:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in a discrete table format with acceptance criteria and corresponding performance metrics for the device itself. The submission focuses on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed equivalent if the materials, treatments, and mechanical properties are substantially similar, and if the biocompatibility and mechanical tests are passed.

The document mentions several tests performed:

Test Category	Specific Test	Outcome (Implied Acceptance)	Notes
Biocompatibility	Citotoxicity Evaluation test	Within acceptable limits (Attachment nº 49)
	Skin sensitization test	Within acceptable limits (Attachment nº 49)
	Salmonella typhirium reverse mutation assay	Within acceptable limits (Attachment nº 49)
	Intramuscular implantation test	Within acceptable limits (Attachment nº 49)
	Intracutaneous reactivity test	Within acceptable limits (Attachment nº 50)
	Pyrogenicity test (USP 151)	Within acceptable limits (Attachment nº 51)
	Sterility (ISO 11737-2)	Sterile (Attachment nº 52)
	Systemic toxicity test	Within acceptable limits (Attachment nº 53)
	Evaluation of sterilization efficacy fixture	Effective sterilization (Attachment n° 54)	Also referred to as Bioburden test in the document.
	Evaluation of sterilization efficacy abutment	Effective sterilization (Attachment n° 55)
Mechanical Tests	Performed by Milan University	Demonstrated effectiveness prior to commercialization	Specific criteria and results are not detailed in the summary (Attachments nº 38, 39 are referenced).
Clinical Study	Multi-centred Clinical Study	Proved effectiveness prior to commercialization	Further details on outcomes or specific metrics are not provided in the summary (Attachment nº 40 is referenced).
Material/Surface	DMA (Double Acid-Etching) for BT-Tite CV3	Equivalent to BT-Tite surface (no material added, no changes in material, just acid-etching performed twice).	This is a description of the surface treatment for BT-Tite CV3 and its equivalence to previously approved surfaces.
	BT-Tite surface for Mini Implant	Obtained by sand-blasting and acid-etching (approved by FDA with K073458)	This describes the surface treatment for Mini Implants.
	BT-Tite surface for Mini Single	Approved by FDA (K073458)	This describes the surface treatment for Mini Single implants.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Biocompatibility & Mechanical Tests: Sample sizes are not explicitly stated in the provided summary.
Clinical Study: Mentioned as a "multi-centred clinical study" (Attachment nº 40). The sample size, country of origin, and whether it was retrospective or prospective are not specified in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable in the context of this 510(k) submission, as it relates to evaluating device performance against a "ground truth" typically seen in ML/AI studies. For mechanical and biocompatibility tests, validated test methods are used, and for the clinical study, patient outcomes would be observed and assessed by medical professionals, but not in the sense of "ground truth establishment" for an AI model.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable to this type of device submission. Adjudication methods are typically used in studies where human readers are establishing "ground truth" or evaluating AI output, which is not the primary focus here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. This is a submission for dental implants, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC comparative effectiveness study was performed in the context of human readers improving with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is an endosseous dental implant; there is no algorithm or AI component involved to perform a standalone evaluation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For biocompatibility tests, ground truth would be established by standard biological assays and thresholds (e.g., cell viability, immune response, pyrogenicity limits).
For mechanical tests, ground truth would be established by engineering specifications and failure criteria.
For the clinical study, the "effectiveness" would be assessed through outcomes data in patients, such as successful osseointegration, stability of prostheses, chewing function restoration, and absence of adverse events, monitored by dental professionals.

8. The sample size for the training set:

This is not applicable as there is no AI/ML model for which a training set would be required.

9. How the ground truth for the training set was established:

This is not applicable for the same reason mentioned in point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "BTLock Next Generation System". The logo consists of a circular emblem on the left, containing the letters "BTL" inside. To the right of the emblem is the text "BTLock" in bold, followed by the words "NEXT GENERATION SYSTEM" in a smaller font size.

K083869

MAR 2 7 2009

ABBREVIATED 510(K) SUMMARY

Submitter's name:	BTLock S.r.l.
Address:	via Madonnetta 97/C
	36075 Montecchio Maggiore
	Vicenza
	Italy
Telephone number:	0039 0444 492609
Fax number:	0039 0444 497647
Contact person:	Ester Battilana
Email:	info@btlock.com
Date of this summary:	December 9th, 2008
Name of the devices:	BT-Tite CV3, Mini Implant, Mini Single, Slot Implant
Common or usual name:	BT-Tite CV3, Mini Implant, Mini Single, Slot Implant
Classification name:	Endosseous Implant (21 CFR 872.3640)

Opening remarks: BTLock is located in Alte Ceccato, a minor part of Montecchio Maggiore. In January 2007 Alte Ceccato was inglobated in the main town and since then the relative postal code (36041) is no longer in use. The new one is 36075. This is the reason why you will find some disagreement from this point of view in the documents we are submitting.

You will find different names of the company in the submission as well. You will see BTLock and Fidelm. It is the same company: Fidelm changed its name in BTLock in 2003 (see attachment n° 12).

Probably in the attachments and in the catalogues you will find different kind of surfaces (HA Coated, Acid-etched): we are not going to export them in the USA and therefore they are not part of this submission.

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The major part of the products you see in the catalogue have already been approved by the FDA with the K073458. We registered recently at FURLS. This is our owner operator number: 10027925.

K083869

BTLock system is already registered as medical device in European union (CE, see attachment n° 41), Taiwan (DOH, see attachment nº 46), Brasil (ANVISA, see attachment nº 47, we are at pp.41), South Korea (KFDA, see attachment nº 48). BTLock quality system is certified by DNV (ISO 9001 and 13485, see attachments nº 43 and 44).

All products codes are included in BTLock Free Trade certificate (see attachment nº 45).

The legally marketed devices to which we are claiming substantial equivalence, according to 807.92, are the following: BT-Tite CV3, Mini Implant, Mini Single, Slot implant.

BT-Tite CV3

BTLock device	Reference	Device name	Manufacturer
BT-Tite CV3	K073458	BT-Tite CV2	BTLock S.r.l.

Description of the device

Sede Commerciale: Via Madonnetta, 97/C 36075 Montecchio Maggiore (VI) Tel. +39 0444 497647 Part. IVA n. 02530390794 Indirizzo Internet: www.btlock.com e-mail info@btlock.com

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etching. This treatment is absolutely equivalent to BT-Tite (no material is added, no changes in the material used for the treatment: just acid-etching is performed twice instead than once).

It is available in 3 diameters (3,75 - 4,5 - 5,5 mm) and 5 lengths (8 - 10 - 11,5 - 13 -16 mm). The technical details of the product are included in its own drawing (see attachment nº 18).

See attachment nº 07 for the brochure of BT-Tite CV3 and the surgical handbook (attachment nº 10) for reference about the surgical protocol which is equivalent to that of the other fixtures of BTLock system.

Intended use

This fixture is intended to be used in maxilla or mandible, for single or multiple replacement, for post-extraction sites and where the implant would be immediately loaded. In case of post-extraction sites it has to be inserted some millimetres under the bone crest. It can be placed in the oral cavity in one or two stage surgical procedure. It is intended for single use only.

When selecting a candidate to implant treatment, some aspects should be carefully considered: patient's expectations and motivations, his/her general health conditions, and the oral hygiene.

Labeling

As the other BTLock lines, BT-Tite CV3 fixtures are packed together with a surgical screw, an assembling screw, and the implant carrier. Once these parts are assembled, they are put in a crystal vial, which is inserted in a blister pack. It is then sent to the gamma-ray sterilization. On the blister pack two little labels are sticked: one for the dentist's record and one for the patient's sheet. The blister pack is then put in a pasteboard package together with an information sheet (which is written in 4 languages: Italian, English, Spanish, Portuguese). On the pasteboard package another label is sticked, which contains the following information about: product description, product code, size (diameter, length), the colour-code (which refers to the diameter), expiry date, manufacturing date, batch number, CE mark, sterile mark, one-time use mark, the indication to read the information sheet, Rx Only, and details of manufacturing company.

For a more detailed description of the labelling and the package please see attachment n° 28 (label symbols), 27 (packaging), 29 (a sample of the external label we paste on the package), and 33 (a sample of the internal label we paste on the package). I attached the English version (attachment n°

ਤ

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and the Italian-English version of the information sheet we put in the packages (att 14).

BTLock device	Reference	Device name	Manufacturer
Mini Implant	K031106	MDI	Imtec Sendac

Mini Implant

Description of the device

The fixture of the mini implant line is machined from titanium and self-threading. They are available in 3 diameters (2 - 2,5 - 3 mm) and 3 lengths (11,5 - 13 - 16 mm). The implant length includes the machine-cut collar (1,5 mm) and the threaded part which features a surface treatment called BT-Tite, which is obtained by the combination of sand-blasting and acid-etching.

It is available in 3 diameters (2 - 2,5 - 3 mm) and 3 lengths (11,5 - 13 - 16 mm).

The technical details of the product are included in its own drawing (see attachment nº 19).

See attachment nº 08 for the brochure of BTLock Mini Implants.

Intended use

BTLock mini implant is intended for use in the upper and/or lower jaw for immediate and long-term stabilization of removable prosthesis in order to restore chewing function to fully edentulous patients. It is intended for single use only. According to the manufacturer's surgical protocol, 4 mini implants should be inserted in order to assure the stabilization of the prosthesis.

Once the implant has been inserted, the surgeon can choose among different prosthetic components: metal ring (in case of low chewing dimension), teflon cap with plastic o-ring, metal cap with o-ring, and retaining cap.

When selecting a candidate to implant treatment, some aspects should be carefully considered: patient's expectations and motivations, his/her general health conditions, and the oral hygiene.

Labeling

The labelling for the Mini Implants is exactly the same as for the BT-Tite CV3.

For a more detailed description of the labelling and the package please see attachment nº 28 (label symbols), 27 (packaging), 30 (a sample of the external label we paste on the package), and 34 (a sample of the internal label we paste on the package). I attached the English version (attachment nº 17) and the Italian-English version of the information sheet we put in the packages (attachment n° 16).

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K083869

Mini Single

BTLock device	Reference	Device name	Manufacturer
Mini Single	K031345	Nobel Direct 3.0	Nobel Biocare

Description of the device

It is a self-threaded and tapered implant made of titanium alloy. The fixture's body features BT-Tite as surface treatment (already approved by FDA, see K073458). This implant has a one-piece design, that is the abutment is integrated to the implant, and an anatomic design. The implant and the abutment are made of the same material.

It is available in 2 diameters (2,5 - 3 mm) and 4 lengths (10 - 11,5 - 13 - 16 mm). The technical details of the product are included in its own drawing (see attachment nº 20). See attachment nº 08 for the brochure of BTLock Mini Implants.

Intended use

This device it is intended to be used in maxilla or mandible in anterior narrow sites of dental arch to replace lateral teeth, dental agenesis and inferior incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only.

It requires a minimally invasive surgery and are designed for one-stage surgical procedure.

When adequate bone and attached gingival are present they can be placed by a flapless surgery, When selecting a candidate to implant treatment, some aspects should be carefully considered: patient's expectations and motivations, his/her general health conditions, and the oral hygiene.

Labeling

The labelling for the Mini Single implants is exactly the same as for the Mini Implants.

For a more detailed description of the labelling and the package please see attachment n° 28 (label symbols), 27 (packaging), 31 (a sample of the external label we paste on the package), and 35 (a sample of the internal label we paste on the package). I attached the English version (attachment n° 17) and the Italian-English version of the information sheet we put in the packages (attachment n° 16).

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K083869

BTLock device	Reference	Device name	Manufacturer
Slot Implant	K052471	Spider Screw	HDC S.r.l.

Description of the device

This device is made of titanium alloy, has a tapered and self-tapping shape. The head has 2 slots, one hole and one neck. The neck is polished (in order not to interfere with soft tissue). It can be loaded immediately.Its smooth threaded surface allows easy removal at the end of treatmet: as a matter of fact because complete osteointegration is neither expected nor desired with this anchorage system because its utilization is temporary.

It is available in 2 diameters (1,6 - 2 mm) and 3 lengths (6 - 7,5 - 9 mm).

See attachment nº 09 (page 58) for the description we provide of BTLock Slot Implants to our customers. The technical details of the product are included in its own drawing (see attachment nº 21).

Intended use

It is intended to be used as temporary intra-oral anchorage unit in the orthodontic treatment in the superior or inferior arch or extra arch in case of edentulous patients, when necessary teeth for the anchorage are absent or the next teeth are compromised from a parodontal point of view. It facilitates the orthodontic movement of teeth. It is removed after orthodontic treatment has been completed. It is intended for single use only. When selecting a candidate to implant treatment, some aspects should be carefully considered: patient's expectations and motivations, his/her general health conditions, and the oral hygiene.

Labeling

The labelling for the Slot implants is exactly the same as for the Mini Implants.

For a more detailed description of the labelling and the package please see attachment nº 28 (label symbols), 27 (packaging), 32 (a sample of the external label we paste on the package), and 36 (a sample of the internal label we paste on the package). I attached the English version (attachment n° 17) and the Italian-English version of the information sheet we put in the packages (attachment n° 16).

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K083869

Identification of the risk analysis method

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

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

Anyway, BTLock has carried on biocompatibility, mechanical tests by the Milan University (see attachment nº 38 (justification of our worst case scenario) and 39) and a multi-centred clinical study (see attachment nº 40) to prove the effectiveness of the devices before commercialization,

Biocompatibility tests include:

· Citotoxicity Evaluation test (see attachment nº 49)
· Skin sensitization test (see attachment nº 49)
· Salmonella typhirium reverse mutation assay (see attachment nº 49)
· Intramuscular implantation test (see attachment nº 49)
· Intracutaneous reactivity test (see attachment nº 50)
· Pyrogenicity test (USP 151) (see attachment nº 51)
· Sterility (ISO 11737-2) (see attachment nº 52)
· Systemic toxicity test (see attachment nº 53)
· Evaluation of sterilization efficacy fixture (see attachment n° 54)
· Evaluation of sterilization efficacy abutment (see attachment n° 55)
Our quality system implies a series of internal and external checks over our products.

Internal checks are described in our quality system handbook and especially in our POS (standard operational procedures) documents. External checks are the followings:

SEM analysis (see attachment nº 57 - 58 - 59)
Bioburden (see attachment nº 54), equivalent to Evaluation of sterilization efficacy for fixture.
We attach also the sterilization contract specifications referred to all fixtures and healing-screws (see attachment nº 56).

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K083869

TEMPORARY MILLABLE ABUTMENT (BTIMCL1)

Image /page/7/Picture/3 description: The image shows a black and white rendering of a lightbulb. The lightbulb has a standard shape, with a rounded top and a screw base. The image is grainy and has a lot of noise, which makes it difficult to see the details of the lightbulb. The screw base is more clearly defined than the rest of the lightbulb.

Description: abutment for the exclusive BTLock system made of plexyglass, available in 5 diameters (3,3 - 3,75 - 4,5 - 5,5 - 6,5 mm). See attachment nº 22 for technical details.

Use: it has to be used as temporary millable abutment in single or multiple restorations.

Differences from other abutments: among the BTLock abutments made of plexiglass, it is the only one that can be used as temporary.

SCREWABLE LOCK ABUTMENT (BTIMP2)

Image /page/7/Picture/8 description: The image shows a close-up of a metal pipe fitting. The fitting has a cylindrical shape with a wider section in the middle and narrower sections at the top and bottom. The surface of the fitting appears rough and textured, suggesting it may be made of cast iron or a similar material.

Description: lock straight neck made if titanium alloy, available in 5 diameters.

Use: indicated for disparallelism, in case of high occlusal stress and in single restorations, for barretained restorations and screwable technique.

Differences from other abutments: it is the straight version of BTLock abutments for screwable technique.

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K083869

SCREWABLE ANGLED ABUTMENT (A/B BTIMPI15/25)

Image /page/8/Picture/2 description: The image shows a close-up of a small, multi-tiered architectural model or sculpture. The structure consists of stacked, geometric shapes, including cylindrical and angular forms. The top section features a wing-like or roof-like element that extends outward, creating a sense of projection. The overall aesthetic is minimalist and abstract, with a focus on the interplay of light and shadow on the various surfaces.

Description: lock neck made of titanium alloy. It is available in 2 inclinations (15° - 25°) and 2 heights (1 - 2,5 mm) according to the gingival thickness. See attachment nº 23 for technical details.

Use: it has to be used for disparallelism, in case of high occlusal stress and in single or multiple restorations.

Differences from other abutments: as the lock screwable abutment, it has to be used for the screwable technique.

LOCK PASSIVE ABUTMENT (BTIMP1)

Image /page/8/Picture/7 description: The image shows a close-up of a cylindrical object with a threaded base. The top portion of the cylinder appears to be transparent or translucent, while the lower part is opaque and darker in color. The object has a stepped design, with the diameter decreasing towards the threaded base.

Description: passive abutment in titanium alloy, antirotational, available in 5 diameters and 3 heights (0 - 1 - 2 mm) according to the gingival thickness.

Use: suitable for single, multiple restorations and bar-retained solutions in the anterior and posterior areas.

Differences from other abutments: among the passive abutments this is the lock version.

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A083869

ROTATIONAL PASSIVE ABUTMENT (BTIMPR1)

Image /page/9/Picture/2 description: The image shows a close-up of a small, cylindrical device with a threaded base. The top portion of the device appears to be transparent or translucent, allowing a view of internal components. The middle section has a more solid, opaque appearance, and the bottom section features a screw thread, suggesting it is designed to be attached to something. The image is in black and white and has a grainy texture.

Description: passive abutment in titanium alloy, rotational, available in 5 diameters and 3 heights (0 -1-2 mm) according to the gingival thickness.

Use: suitable for multiple restorations and barretained solutions in the anterior and posterior areas.

Differences from other abutments: among the passive abutments this is the rotational version.

IMMEDIATE-LOADING ABUTMENT WITH ROTATIONAL CAP (BTIMP3)

Image /page/9/Picture/7 description: The image shows a close-up of a small, cylindrical object with a threaded end. The object appears to be made of metal and has a smooth, polished surface on the top portion. The bottom portion has a darker color and a more complex shape, with a series of ridges and grooves leading to the threaded end. The threads are fine and evenly spaced, suggesting that the object is designed to be screwed into something.

Description: lock abutment in titanium alloy. Cementable cap included in the package. Available in five diameters.

Use: suitable for provisional prosthetic solutions for single and multiple restorations and immediateloading.

Differences from other abutments: in this version the

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Image /page/10/Picture/0 description: The image shows a handwritten number, K083869, in black ink. The numbers are written in a cursive style, with some of the numbers connected to each other. A line is drawn underneath the number.

IMMEDIATE-LOADING ABUTMENT WITH FIXED CAP (BTIMP4)

Image /page/10/Picture/2 description: The image shows a dental implant and a white, blurry object above it. The implant is made of metal and has a screw-like structure at the bottom. The implant has a cylindrical shape with several horizontal grooves. The white object above the implant is blurry and its shape is not clear.

Description: lock abutment in titanium alloy. Cementable cap included in the package. Available in five diameters.

Use: suitable for provisional prosthetic solutions for single and multiple restorations and immediateloading.

Differences from other abutments: in this version the cap is fixed.

PROVISIONAL LOCK ABUTMENT FOR IMMEDIATE LOAD (BTIPML1)

Image /page/10/Picture/7 description: In the image, there is a close-up of a metal object that appears to be a type of fastener or connector. The object has a cylindrical shape with multiple stacked sections, each slightly wider than the one below it, creating a stepped appearance. The bottom of the object features a threaded section, indicating it is designed to be screwed into a corresponding part. The overall impression is of a sturdy, machined component, possibly used in mechanical or engineering applications.

Description: lock abutment in titanium alloy. The retention grooves help to fix the acrylic material of the provisional prosthesis. Available in five diameters. See attachment nº 24 for technical details.

Use: to be used for provisional prosthesis in single restorations and for immediate-loading.

Differences from other abutments: this lock version * is for single restorations.

Sede Commerciale: Via Madonnetta, 97/C 36075 Montecchio Maggiore (VI) Tel. +39 0444 492609 - Fax +39 0444 497647 Part. IVA n. 02530390794 Indirizzo Internet: www.btlock.com e-mail info@btlock.com

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K083869

PROVISIONAL ROTATIONAL ABUTMENT FOR IMMEDIATE LOAD (BTIPMR1)

Image /page/11/Picture/2 description: The image shows a metal object with a cylindrical shape. The object has a series of stacked, disc-like sections at the top, which gradually taper down to a narrower base. At the very bottom, there is a threaded screw-like component. The object appears to be a mechanical part, possibly a component used in machinery or engineering applications.

Description: rotational abutment in titanium alloy. The retention grooves help to fix the acrylic material of the provisional prosthesis. Available in five diameters. See attachment nº 25 for technical details.

Use: to be used for provisional prosthesis in multiple restorations and for immediate-loading.

Differences from other abutments: the rotational version is for multiple restorations.

Please, see attachment nº 37 for a sample of the labelling for prosthetic components (which reports information about: the product description, product code, size (diameter and length), manufacturing date, batch number, CE mark, one time use mark, details of manufacturing company) and the information sheet. For these devices gamma-ray sterilization is not necessary, this is the reason why labelling is much more simpler.

Instrumentation is exempt from 510K. Anyway, in case you need the technical drawings or some information about the accessories necessary to insert these implants, do not hesitate to contact me.

Ester Battilana BTLock S.r.l.

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Image /page/12/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

MAR 2 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ester Battilana BTLock s.r.1. Via Madonnetta, 97/C 36041 ALTE di MONTECCHIO MAGGIORE VICENZA, ITALY

Re: K083869

Trade/Device Name: BT-Tite CV3. Mini Implant, Mini Single, Slot Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosscous Dental Implant Regulatory Class: II Product Code: DZE & NHA Dated: March 18, 2009 Received: March 18, 2009

Dear Ms. Battilana:

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 ffor 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.

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Page 2 - 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 (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.

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 procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Saigle Y. Michael Davis

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K083869

Indications for Use

Device Name: BT-Tite CV3, Mini Implant, Mini Single, Slot Implant

Indications for Use:

Mini Implant: It is intended to be used in maxilla or mandible for immediate and long-term stabilization of removable prosthesis.

Mini Single: It is intended to be used in maxilla or mandible in anterior narrow sites of dental arch, to replace lateral teeth, dental agenesis and inferior incisors.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Susan Turner

Page 1 of 1

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

510(k) Number: K082869

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.