K962014 · Implant Innovations, Inc. · DZE · Oct 18, 1996 · Dental
Device Facts
Record ID
K962014
Device Name
3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.
Applicant
Implant Innovations, Inc.
Product Code
DZE · Dental
Decision Date
Oct 18, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3640
Device Class
Class 2
Device Story
Device consists of pre-sterilized, single-use, disposable surgical instruments including pilot drills, twist drills, round drills, taps, burs, counterbores, and countersinks. Constructed from AISI M2 high-speed surgical steel, these instruments are used by dentists or physicians in clinical settings to prepare bone sites for dental implants. Instruments feature depth markings and diameter labels to assist clinicians. Compared to reusable stainless steel predecessors, these single-use instruments provide sharper cutting edges, improving drilling efficiency and reducing bone trauma. Instruments are supplied in rigid copolyester trays, sterilized via Co60 irradiation. Clinicians use these tools to create precise osteotomies; proper use is intended to prevent overheating of bone and ensure successful implant osseointegration. Output is the physical preparation of the surgical site.
Clinical Evidence
Bench testing only. No clinical data provided. Sterilization validation performed per AAMI standards to achieve a Sterility Assurance Level (SAL) of 10^-6 using Co60 irradiation.
Technological Characteristics
Materials: AISI M2 high-speed surgical steel. Form factor: Various dental/surgical drill and bur geometries with depth markings. Sterilization: Co60 irradiation (min 25.0 kGy). Connectivity: None. Software: None.
Indications for Use
Indicated for use by licensed dentists or physicians for bone cutting procedures during dental implant surgery. Contraindicated in cases where remaining jaw bone is insufficient to support implants.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Implant Innovations Inc. Drills and Burs (K891615)
Reference Devices
Nobelpharma Branemark System Drills and Screw Taps
Brasseler, Inc. Surgical Instruments
The Anspach Effort, Inc. High Speed Drills
Submission Summary (Full Text)
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OCT 17 1996
K962014
3071 Continental Drive
West Palm Beach, FL 33407
1-800-443-8166 (407) 840-2600
FAX (407) 840-2660
AT INNOVATIONS
# OCT 18 1996
510(k) SUMMARY
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.
1. CLASSIFICATION NAME:
Bone cutting instrument and accessories.
2. COMMON/USUAL NAMES:
Dental/Surgical Pilot Drills, Twist Drills, Round Drills, Taps, Burs, Counterbores, Countersinks, Cylinder Burs, Tri-Spade Drills, Trephine Burs, etc.
3. PROPRIETARY NAME:
3i Single Use, Disposable drills, Taps, Burs, etc.
4. ESTABLISHMENT REGISTRATION NUMBER: 1038806
5. 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.
6. 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.
# 8. 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.
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 periapical radiographs are essential to determine anatomical landmarks, occlusal conditions, periodontal 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,
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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.
END
William S. Conety
Regulatory Affairs
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
