TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT
K101880 · Zimmer Dental, Inc. · DZE · Oct 1, 2010 · Dental
Device Facts
Record ID
K101880
Device Name
TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT
Applicant
Zimmer Dental, Inc.
Product Code
DZE · Dental
Decision Date
Oct 1, 2010
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3640
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Tapered Screw-Vent® T Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The Tapered Screw-Vent® P Implants are designed for use in the maxilla or mandible for loading after a conventional healing period. Implants may be used to replace one or more missing teeth.
Device Story
Endosseous dental implants; titanium alloy construction; Tapered Screw-Vent T features MTX surface texture and collar grooves; Tapered Screw-Vent P features MTX texture, collar grooves, and Cancellous-Structured Titanium (CSTi) porous coating for bone ingrowth. Implants are tapered with triple-lead threads to facilitate implantation and osseointegration. Used by dental clinicians in clinical settings to replace missing teeth. Output is the physical implant structure integrated into the jawbone to support prosthetic teeth. Benefits include restoration of dental function and aesthetics.
Clinical Evidence
No clinical studies were conducted. Substantial equivalence is supported by bench testing performed in accordance with FDA guidance for root-form endosseous dental implants.
Technological Characteristics
Endosseous dental implants; titanium alloy; Cancellous-Structured Titanium (CSTi) coating; MTX surface treatment; tapered body with triple-lead threads; 4.7mm and 6.0mm diameters; non-software device.
Indications for Use
Indicated for patients requiring replacement of one or more missing teeth in the maxilla or mandible. Tapered Screw-Vent T Implants allow for immediate loading (with good primary stability/occlusal load) or conventional loading. Tapered Screw-Vent P Implants are indicated for conventional loading only.
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.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter Z inside of a circle. Below the circle is the word "zimmer" in a bold, sans-serif font, with a line underneath it, and the word "dental" in a smaller, sans-serif font below the line.
| Zimmer Dental |
|---------------|
|---------------|
1900 Aston Avenue Carlsbad. CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
510k No .:
A5-1 Page No .:
2010
OCT 1
10/880
## Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
# 510(k) SUMMARY (21CFR807.92(a))
- 1. Submitter's Information:
Zimmer Dental Inc. Name:
1900 Aston Ave.
1900 Aston Ave. Address: Carlsbad, CA 92008
760-929-4300 Phone:
Contact: Melissa Burbage
Date Prepared: June 29, 2010
- 2. Device Name:
Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant
Device Classification Name: Endosseous Dental Implant
## 2. Predicate Device(s):
- a. Zimmer Dental Tapered Screw-Vent® Implant System
- i. 510(k) Numbers: K011028 / K953101 / K013227 / K061410 / K072589
- b. NobelReplace Tapered Conical Connection
- i. 510(k) Number: K062566
- c. Spline X Implant
- i. 510(k). Number: K962576
#### 4. Device Description:
The Tapered Screw-Vent® T Implant is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease if implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads.
The Tapered Screw-Vent® P Implant is an endosseous dental implant. The implant is composed of titanium alloy and Cancellous-Structured Titanium (CSTi) coating. The implant section is designed for ease of implantation and
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| 510(k) No. | K101880 |
|------------|---------|
| Page No. | A5-2 |
with greater surface area for osseointegration. The CSTi coating is designed to allow for bone ingrowth. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads.
#### 5. Indications for Use:
The Tapered Screw-Vent® T Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
The Tapered Screw-Vent® P Implants are designed for use in the maxilla or mandible for loading after a conventional healing period. Implants may be used to replace one or more missing teeth.
#### 6. Device Comparison:
The Tapered Screw-Vent® T Implant is the same as the predicate Tapered Screw-Vent Implant in the implant/abutment connection, implant body design, materials, and manufacturing. This device has been modified to add the MTX texture to the top of the implant and add small grooves on the implant collar similar to the predicate NobelReplace Tapered implant. The new device will feature hydroxylapatite coating, hydroxylapatite coating with additional Zimmer Dental MP-1® processing, or MTX surface equivalent to existing Zimmer Dental implants. The new implant will be offered in 4.7mm and 6.0mm diameters.
The Tapered Screw-Vent® P implant is the same as the predicate Tapered Screw-Vent® implant in the implant/abutment connection, general implant body design, materials, and manufacturing. The modifications to this device include addition of MTX texture to the top of the implant and the addition of small grooves to the implant collar similar to the predicate NobelReplace Tapered implant. Another modification includes a porous surface created using Cancellous-Structured Titanium (CSTi). This is the same porous surface on the predicate Spline X implant (K962576). The new implant will be offered in 4.7mm and 6.0mm diameters.
#### 7. Basis for Substantial Equivalence:
The new devices are substantially equivalent to the predicate devices, the indications for Tapered Screw-Vent® T Implant are the same as the Tapered increations for the indications for the Tapered Screw-Vent® P implant have been reduced and only have indications for use in the maxilla or mandible for loading after a conventional healing period. The new devices have the
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| 510(k) No. | K101880 |
|------------|---------|
| Page No. | A5-3 |
same technological characteristics as the previously cleared predicated devices, and it can be demonstrated that the devices are as safe and effective as the predicate devices. The new devices do not raise any different questions regarding safety and effectiveness as compared to the predicate devices. The Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant, as designed and manufactured, is as safe and effective as the predicate devices and therefore determined substantially equivalent to the referenced predicate devices.
#### 7.1 Non-clinical test summary:
The new devices have been subjected to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as a dental implant system and following all indications set out in FDA Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Functional laboratory testing preformed in foreseeable operating conditions showed correct operation of the device per its intended use.
### 7.2 Clinical test summary:
No clinical studies were conducted to evaluate the performance of this device.
#### 8. Conclusion:
We believe that the Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant constitute a safe, reliable and effective dental implant, meeting all the declared requirements of the intended use. The devices present no new adverse health effects or safety risks to patients when used as intended.
We conclude that the new devices are safe and effective for the indications for use, and based on the information included in this submission, we believe that substantial equivalence of the proposed devices with the legally marketed predicate devices may be established.
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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's symbol, which is a stylized representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. A dotted line is also present in the image.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
#### DCT 1 2010
Ms. Melissa Burbage Regulatory Affairs Manager Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
Re: K101880
Trade/Device Name: Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 3, 2010 Received: September 14, 2010
Dear Ms. Burbage:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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### Page 2- Ms. Burbage
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/5/Picture/0 description: The image shows a logo for Zimmer Dental. The logo features a stylized letter "Z" inside a circle. Below the circle, the word "zimmer" is written in a bold, sans-serif font. Underneath "zimmer", the word "dental" is written in a smaller, less bold font.
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant
Indications For Use:
The Tapered Screw-Vent®T Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
The Tapered Screw-Vent® P Implants are designed for use in the maxilla or mandible for loading after a conventional healing period. Implants may be used to replace one or more missing teeth.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runos
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of Andolinoon - 30.
Infection Control, Dental Devices
510(k) Number: K101880
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.
