Manufacturer registered with FDA
Bioclear Matrix Systems, LLC
Tacoma, WA, United States. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 31
- 510(k) clearances
- 0as applicant
- Markets registered in
- 645 registrations outside the US
- Establishments
- 1United States
Registered in 6 markets
Where regulators' registries name Bioclear Matrix Systems, LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Bioclear Matrix Systems, LLC | 8 device types | — | Below |
| South Korea | MFDS | Manufacturer | BioclearMatrixSystemsBioclear Matrix Systems · BioclearMatrixsystems · +2 | 26 | 2016–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Bioclear Matrix Systems | 8 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Bioclear Matrix Systems LLC | 7 | 2022–2022 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BIOCLEAR MATRIX SYSTEMS, LLC | 2 | 2024–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BIOCLEAR MATRIX SYSTEMSBIOCLEAR MATRIX SYSTEMS,LLC | 2 | 2016–2017 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Bioclear Matrix Systems, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Adjustable Push-PullClark ExplorerCurved Micro PliersCurved Sculpting PaddleEsthetic Proportion Gauge/ContrastorInterproximal CarverMatrix Sculpting ScissorsMicro HemostatPush-PullRockStar Polisher 4 moreRockStar Sculpting and Polishing DiscsScalpel HandleSculpting PointTwinRing | 2007 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | TruContactTrue Contact 2 | 2018 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | Magic Mix Cups | 2023 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Bioclear Rubber Dam StampBlack Triangle GaugeEvolve Matrix Height Indicator | 2011 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Diamond Wedge | 2018 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | TwinRing Forceps | 2018 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Blasting PowderDual-Color Disclosing SolutionMagic Mix PrePolish | 2018 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Bioclear MatrixBiofit MatrixBT MatrixEvolve MatrixTSS MatrixVeneer 360 Matrix | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Bioclear Matrix Systems, LLCFDA reg. 3006990004 | Tacoma, WA, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9107200). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.