K051502 · Thommen Medical AG · DZE · Jun 21, 2005 · Dental
Device Facts
Record ID
K051502
Device Name
SPI DENTAL IMPLANT
Applicant
Thommen Medical AG
Product Code
DZE · Dental
Decision Date
Jun 21, 2005
Decision
SESE
Submission Type
Special
Regulation
21 CFR 872.3640
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Thommen SPI® Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® Dental Implants can be loaded immediately if they are for crowns, bridges or overdentures. SPI® Dental Implants can be loaded immediately if they are for crowns, bridges or overdentures in the mandibular arch or six implants in the maxillary arch.
Device Story
SPI® Dental Implant System, TST Surface, is a self-tapping, root-form, endosseous dental implant; manufactured from commercially pure grade titanium. Device features smooth machined transgingival portion and TST-treated surface for bone contact. Surgically placed by dental professionals in clinical settings to support prosthetic restorations (crowns, bridges, overdentures). Immediate or delayed loading protocols supported. TST surface modification intended to enhance osseointegration. Device provides structural foundation for dental rehabilitation, improving patient masticatory function and aesthetics.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on design, material, and intended use similarities to the predicate device.
Technological Characteristics
Endosseous root-form dental implant; material: commercially pure grade titanium (ASTM F67, ISO 5832-2); surface: TST treatment; form factor: self-tapping; sterilization: gamma irradiation (25 kGy).
Indications for Use
Indicated for patients requiring dental restoration via crowns, bridges, or overdentures in the maxillary or mandibular arch. Contraindicated for SPI® CONTACT and ELEMENT implants (ø 3.5 mm) in areas subject to pronounced rotation or large bending movements, specifically: posterior teeth restoration, single-tooth restoration of canines and central incisors in the upper jaw, and applications involving retentive anchors.
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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510(k) Summary
# Special 510(k): Device Modification
# SPI® Dental Implant System, TST Surface
## ADMINISTRATIVE INFORMATION
502
.
| Manufacturer Name: | Thommen Medical AG<br>Hauptstrasse 87<br>CH-4437 Waldenburg<br>Switzerland<br>Telephone +41 61 965 90 20<br>FAX +41 61 965 90 21 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Orlando Antunes |
DEVICE NAME
Classification Name: Trade/Proprietary Name: Common Name:
Implant, Endosseous, Root-Form (DZE) SPI® Dental Implant Endosseous dental implant
# ESTABLISHMENT REGISTRATION NUMBER
The Establishment Registration number for Thommen Medical AG is 3003836985. The Owner/Operator number is 9051144.
#### DEVICE CLASSIFICATION
FDA has classified endosseous dental implants as a Class II device (21 CFR 872.3640 according to revision 69 FR 26307, May 12, 2004). The product code for "Implant, Endosseous, Root-Form" is DZE.
#### CONFORMANCE WITH PERFORMANCE STANDARDS
No performance standards applicable to endosseous dental implants have been established by FDA. However, the Thommen dental implant meets the chemical and mechanical requirements of ASTM F67 and ISO 5832-2.
#### PREDICATE DEVICE INFORMATION
The principal predicate device for this modification is the Thommen Medical AG, SPI® Dental Implant System, cleared by FDA under K0030345, K022038, K030689, K034014.
## PACKAGING/LABELING/PRODUCT INFORMATION
Thommen SPI® Dental Implants will be packaged in a radiation sterilizable package consisting of a primary container, with implant and auxiliary parts, sealed with a peel-off wrapping. The sterile packs will be grouped into storage packs. Sterilization will be accomplished by means of Co°
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K051502
510(k) Summary _______________________________________________________________________________________________________________________________________________________________
gamma irradiation at a nominal dose of 25 kGy (2.5 Mrad). Sterilization will be validated by the gamma inadiation at a nominal dose of 20 11137 Sterilization of Health Care Products — Radiation bloburden method, according to 100 TTS7 Storillation of Medical AG intends to meet for the Stemization: The Stemlity acourance level (evice is not represented to be "pyrogen free."
#### INTENDED USE
The Thommen SPI® Dental Implant System is intended to be surgically placed, either i he Thommen of 1 - Donal Implant of the maxillary and/or mandibular arch to provide support innnediately of delayed, in the bons of the manaly managements can be loaded immediately if they are for crowns, bridges of overdentures. Of I - Dontal implants in the maxillary arch.
Contraindications for the use of SPI®CONTACT implant ø 3.5 mm and SPI®ELEMENT implant ø 3.5 mm:
5.3 frim.
These implants are not suitable for applications in areas where pronounced rotation and These implants are not sultable for applications in arguested to large bending movements.
- Restoration of posterior teeth in the upper or lower jaw -
- Single-tooth restoration of canines and central incisors in the upper jaw -
- Any application involving retentive anchors ..
#### DEVICE DESCRIPTION
The design of this implant has been modified to use a new surface treatment that will be marketed The design of this implant Tax boon from of the SPI® Dental Implant System as the of I Demar implant TOT Sunacouse with the modified implant, and will be sold under the SPI® Dental Implant System name.
The Thommen SPI® Dental Implant System with TST Surface (the modified design) is a self tapping, root form, endosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transgingival portion and and treated with the TST implant ouridos to omooth to contact bone. The modified TST Surface is available on all Sunate procose, in the around system is constructed of materials that have a long clinical history of proven acceptance and performance.
#### EQUIVALENCE TO MARKETED PRODUCT
The modified SPI® Dental Implant TST Surface has the following similarities to the predicates:
- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same basic design,
- · incorporates the same materials, and
- · is packaged and sterilized using the same materials and processes.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
JUN 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thommen Medical, AG C/O Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K051502
K051502
Trade/Device Name: SPI® Dental Implant System, TST Surface Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: June 3, 2005 Received: June 7, 2005
Dear Mr. Larson:
:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your bection 910(t) procession is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the encreating to the enactment date of the Medical Device interstate conminence pror to thay 20, 1976, and existed in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the Federal F00d, Drug, and Cosment 110 (Pres) ............................................................................................................................... approval appreadon (1 Mr.). I The general controls provisions of the Act include confors provisions of the Fist - Inc. Jisting of devices, good manufacturing practice, requirements for aibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (see above) into examines. Existing major regulations affecting to (FMA), It inay of Subject to back address of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Sous receinents concerning your device in the Federal Register.
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Page 2 - Mr. Larson
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualice of a successor its with other requirements
mean that FDA has made a determination that your career Federal agencies mean that FDA nas made a decemmanon that 50 an administered by other Federal agencies.
of the Act or any Federal statutes and regulations administration to: penistration of the Act or any rederal statutes and regirements, including, but not limited to: registration
You must comply with all the Act's requirements and manufacturing prestice You must comply with an the Act 3 requirements, made good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); group manufacturing practice and listing (21 CPR Part 807), labeling (21 CFR regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and i requirements as set forth in the quality systems (QD) regarities (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)
the success of the support of all and start of the spivalence of your device to This letter will allow you to begin marketing your as fromwalerse of your device to a
premarket notification. The FDA finding of substantial equivalerseand thus, new premarket notification. The PDA miding of babbatines of a vour device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), If you desire specific advice for your device on our sales . Also, please note the regulation please contact the Office of Comphanee at (210) 210 - 11 - 1 CFR Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21CFR Part 8) entified, "Misbranding by reference to promation on your responsibilities under the Act from the may obtain other general miorination on your responser Assistance at its toll-free Division of Simall Manazara
number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
(051507
Applicant: Thommen Medical AG
510(k) Number (if known):
Device Name: SPI® Dental Implant System, TST Surface
Indications for Use:
The Thommen SPI® Dental Implant System, TST Surface, is intended to be surgicaly placed, The Thommen STT - Denan Implant By Ren, the maxillary and/or mandibular acchton or distancediately either immediately or delayed, in the both of the mazinal Junlants can be loaded immediately if
support for crowns, bridges or overdentures. SPI® Dental Implants can be loads support for crowns, bridges of overdents in the mandibular arch or six implants in the maxillary arch.
Contraindications for the use of SPI® CONTACT implant ø 3.5 mm and SPI® ELEMENT implant ø 3.5 mm:
miplant 0 3.5 mm.
These implants are not suitable for applications in areas where pronounced rotation and I hese inipiants are not sunable for uppers implant to be subjected to large bending movements.
- Restoration of posterior teeth in the upper or lower jaw -
- Single-tooth restoration of canines and central incisors in the upper jaw -
- Any application involving retentive anchors -
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mulley for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control Dental De
Page of
510(k) Number: K 0515
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.
