(148 days)
Not Found
No
The device description focuses on the material and design of surgical drills, taps, and burs, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device description indicates that the drills, taps, and burs are used to prepare the jaw bone for implants, which is an interventional/surgical tool rather than a therapeutic device.
No
Explanation: The device description indicates that the product consists of "drills, taps, and burs" used for surgical procedures on "jaw bone" by a "licensed dentist or physician". These are surgical tools, not devices designed for diagnosing medical conditions.
No
The device description explicitly states the device is comprised of physical components (drills, taps, and burs) made of "High Speed Surgical Steel". There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator for IVDs. IVDs have specific intended uses related to diagnosing diseases or conditions.
- Device Description: The description details surgical tools (drills, taps, burs) used for preparing the jaw bone for dental implants. This is a surgical procedure, not an in vitro diagnostic test.
- Anatomical Site: The device is used on the "jaw bone," which is an in vivo application (within the body), not an in vitro application (outside the body).
- No mention of biological samples: There is no mention of the device being used with biological samples like blood, urine, or tissue, which are typical for IVDs.
- No mention of diagnostic purpose: The description focuses on the mechanical function of the tools for bone preparation, not on diagnosing any condition.
Therefore, based on the provided text, this device is a surgical instrument used in dental procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
872.4120, 872.4130
Device Description
The proposed pre-sterilized, single-use, disposable drills, taps and burs (3i UniSystem) will be of the same design as previous products but will be constructed of "High Speed Surgical Steel" per AISI M2. All 3i drills are marked at the appropriate depth lengths to assist the clinician in proper drilling and are labeled with the correct drill diameter(s). Each drill is also identified as a "3i" device. Pre-sterilized, single use disposable drills, taps and burs will be packaged in rigid xxxx trays offering greater protection from damage, and will be labeled as "single use, disposable".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jaw bone, lower jaw, upper jaw, maxillary sinus, labial and lingual plates, mandibular canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed dentist or physician
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)
Not Found
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.
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
§ 872.3640 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.
0
KG2014
3i
NT INNOVATIONS®
3071 Continental Drive West Palm Beach, FL 33407 1-800-443-8166 (407) 840-2600 FAX (407) 840-2660
OCT 1 8 1996
510(k) SUMMARY
OCT 17 1996
PRE-STERILIZED, SINGLE USE, DISPOSABLE DRILLS, TAPS AND BURS To the Requestor:
This information is taken directly from the original Pre-Market Notification [510(k)], submission, provided to the United States Food and Drug Administration. No information regarding safety or efficacy has been deleted from that submission, for this summary.
-
- CLASSIFICATION NAME:
Bone cutting instrument and accessories.
- CLASSIFICATION NAME:
-
- COMMON/USUAL NAMES:
Dental/Surgical Pilot Drills, Twist Drills, Round Drills, Taps, Burs, Counterbores, Countersinks, Cylinder Burs, Tri-Spade Drills, Trephine Burs, etc.
- COMMON/USUAL NAMES:
-
- PROPRIETARY NAME:
3i Single Use, Disposable drills, Taps, Burs, etc.
- PROPRIETARY NAME:
-
- ESTABLISHMENT REGISTRATION NUMBER: 1038806
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- CLASSIFICATION:
Bone cutting instruments and accessories, per Section 872.4120 are classified as Class II devices.
Intraoral dental drills, per Section 872.4130 are classified as Class I devices, exempt from Pre-Market Notification.
3i received marketing clearance for drills taps and burs on or about 04/17/89 - K891615. In this submission Surgical Drills were classified by FDA as Class I devices. These drills were constructed of Stainless Steel, were not offered pre-sterile and were reusable.
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- PERFORMANCE STANDARDS: Unknown
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7. FORM:
The proposed pre-sterilized, single-use, disposable drills, taps and burs (3i UniSystem) will be of the same design as previous products but will be constructed of "High Speed Surgical Steel" per AISI M2. All 3i drills are marked at the appropriate depth lengths to assist the clinician in proper drilling and are labeled with the correct drill diameter(s). Each drill is also identified as a "3i" device.
Pre-sterilized, single use disposable drills, taps and burs will benefit both user and patient in that the material used in construction is capable of obtaining a much sharper cutting edge, providing for a more gentle surgical drilling process by improving efficiency in drilling (sharper drills = improved drilling efficiency with less trauma to remaining bone).
Pre-sterilized, single use disposable drills, taps and burs will be packaged in rigid xxxx trays offering greater protection from damage, and will be labeled as "single use, disposable". Also, the proposed pre-sterile, single use disposable drills, taps and burs will be significantly less expensive for the clinician.
-
- PACKAGING/LABELING:
Packaging will consist of a rigid xxxx Copolyester rigid film tray, in single and multiple packs, sealed with foil laminate lidding and pouching material, and labeled with the following minimum information.
- PACKAGING/LABELING:
Catalog Number:
- Description: SINGLE USE, XXXXXX DRILL (TAP, BUR, ETC.) "Product catalog name/size, etc"
Lot Number: "sterile lot number" "STERILE"
FOR SINGLE USE ONLY. DO NOT RE-STERILIZE/REUSE.
Cautions: Sterility not certified (guaranteed) if container or seal is opened or damaged.
"United States federal law restricts device to sale, distribution, or use by or on the order of a licensed dentist or physician".
Manufactured by: Implant Innovations, Inc 3071 Continental Drive West Palm Beach, FL 33407 USA
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Sterilization of the proposed drills, taps and burs shall be accomplished using Co60 Irradiation, at a minimum dose of 25.0 kGy (2.5 mRads), achieving a Sterility Assurance Level (SAL) of ten to the minus six.
Validation of sterilization process shall be accomplished as specified by the Association for the Advancement of Medical Instrumentation. Irradiation sterilization shall be accomplished by an FDA registered irradiation sterilization facility.
The proposed drills, taps and burs differ from original designs in that the originals were constructed of surgical grade stainless steel, distributed non-sterile and were reusable. Sterility was accomplished by the clinician, using an "Auto" or "Chem" clave process.
9. CONTRAINDICATIONS:
Drilling for implant placement should not be undertaken in any case where remaining jaw bone is too diminished to support implants.
10. WARNINGS:
For safe and effective use of any surgical device or equipment including drills, it is strongly recommended that specialized training be undertaken since surgical techniques are highly specialized and complex procedures.
11. PRECAUTIONS:
Thorough screening of prospective surgical candidates must be performed. Visual inspection as well as panoramic and pariapical radiographs are essential to determine anatomical landmarks, occlusal conditions, pariodontal status, and adequacy of bone. Lateral cephalometric radiographs, CT Scans, and tomograms may also be beneficial.
12. ADVERSE EFFECTS:
In dental implant surgery, improper drilling techniques or use of incorrect drills can result in loss of implant anchorage (failure to osseointegrate) or loss of the prosthesis after surgery. Lack of quantity or quality of
remaining bone, infection, poor patient oral hygiene or cooperation, and generalized diseases (diabetes, etc.) are other potential causes for loss of fixture anchorage.
13. SURGICAL COMPLICATIONS:
The surgical procedure has risks, including localized swelling, dehiscence, tenderness of short duration,
3
edema, hematoma, or bleeding. Numbness of the lower lip and chin region following lower jaw surgery, and of the tissue beside the nose following upper jaw surgery, is a possible side effect of the surgery. Though it would most probably be of a temporary nature, in very rare cases numbness has been permanent. Gingival/Mucosal (gum tissue) ulceration, tissue reaction, or infection may occur, but generally responds to local care.
14. SUBSTANTIAL EQUIVALENCE:
Pre-Sterilized, single use disposable drills are used for both dental and orthopedic procedures, and are manufactured/distributed by numerous manufacturers including among others:
Implant Innovations Inc. Drills and Burs. PMN: K891615;
Nobelpharma, "Branemark System Drills and Screw Taps";
Brasseler, Inc. Surgical Instruments; and,
The Anspach Effort, Inc. High Speed Drills and cutting tips for Right and Contra Angle cutter applications.
15. 510(k) CERTIFICATION AND SUMMARY FOR SUBMISSION:
I certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for Endosseous Dental Implant systems, including drills, taps and Burs.
Endosseous Implants (including drills, taps and burs):
Failure of the implant to osseointegrate or loss of osseointegration can be caused by improper patient selection (patients with systemic diseases which affect bone physiology, patients with habits such as bruxing or clenching, patients who are physically or psychologically unable to carry out proper implant hygiene, heavy smoking or alcohol use), by improper surgical technique, overheating of bone by improper technique or use of dull drills, taps or burs, or improper case planning or restorative technique (over-loading of implants through improper placement, use of an insufficient number of implants or excessive cantilever). Improper implant processing by the manufacturer or improper handling by the customer, resulting in contamination, can also effect osseointegration.
Fracture of implants can occur, particularly in implants with apical cross-holes. Fracture occurs either on
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insertion of screw-type implants due to excessive torque (improper surgical technique such as an error in drill selection) or in service due to loss of bone.
Fracture of abutments and abutment screws occurs in implant systems and is usually attributed to factors within the control of the implant team, such as lack of passive fit of the restoration or excessive cantilever, or within the control of the patient, such as bruxing.
Other types of safety and efficacy problems which have been observed for endosseous dental implant systems are local soft tissue degeneration and bone resorption, paresthesia, perforation of the maxillary sinus, perforation of labial and lingual plates, local and systemic infection, prosthetic framework fracture, nerve injury, bone fracture, injury to adjacent teeth and their supporting bone, oroantral or oronasal fistula, gingival hyperplasia, soft tissue overgrowth, perforation of the gingiva by the healing screw, mucosal abscess, displacement of the implant into the mandibular canal, hemorrhage of the floor of the mouth due to transection of the sublingual artery and breakage of drill tip, requiring surgical removal.
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William G. Conety
Regulatory Affairs