Manufacturer registered with FDA
Meta Biomed Co, Ltd
Colmar, PA, United States. Lists 18 dental device types with FDA across 3 registered establishments, and holds 24 510(k) clearances as applicant.
- Device types listed
- 18
- Brands and models
- 38
- 510(k) clearances
- 242003–2024
- Markets registered in
- 173,286 registrations outside the US
- Establishments
- 3South Korea, United States
510(k) clearances per year, 2000–2026
Registered in 17 markets
Where regulators' registries name Meta Biomed Co, Ltd 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 | Meta Biomed Co, Ltd | 24 clearances | 2003–2024 | Below |
| European Union | EUDAMED | Manufacturer | META BIOMED CO., LTD. | 2,924 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | META BIOMED CO., LTD.META SYSTEMS CO., LTD. ALSO DOING BUSINESS AS S-DENTI CO., LTD. | 96 | 2009–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | META BIOMED CO., LTD.META SYSTEMS CO., LTD. also doing business as S-Denti Co., Ltd. · META BIOMED CO., LTD | 45 | 2005–2025 | Pure Global AI |
| Egypt | EDA | Manufacturer | Meta Biomed Co., Ltd.,META BIOMED CO., LTD, · Meta Biomed Co., Ltd, · +2 | 40 | 2024–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | META BIOMED CO., LTD.Meta Biomed Co.Ltd. | 28 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Meta Biomed Co LtdMETA SYSTEMS CO LTD also doing business as S-Denti Co Ltd | 25 | 2004–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | META BIOMED CO., LTDMETA BIOMED CO LTD · META BIOMED CO.LTD · +2 | 22 | — | Pure Global AI |
| Japan | PMDA | Registration holder | ＭＥＴＡ ＢＩＯＭＥＤ ＣＯ．，ＬＴＤ．ＭＥＴＡ ＢＩＯＭＥＤ ＣＯ．，ＬＴＤ | 22 | 2012–2017 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | META BIOMED CO., LTDMETA BIOMED CO., LTD. | 20 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | META BIOMED CO., LTD. | 14 | — | Pure Global AI |
| China | NMPA | Registration holder | 美塔生物医疗有限公司META BIOMED CO., LTD.美塔生物医疗有限公司META BIOMED CO., LTD · 美塔生物医疗有限公司META BIOMED CO.,LTD · +2 | 12 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | META BIOMED CO., LTD. | 12 | 2023–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | META BIOMED CO., LTD.META BIOMED CO. LTD | 10 | 2021–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | META BIOMED CO. LTD.META BIOMED CO,. LTD. | 7 | 2007–2021 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | Meta Biomed CO. LtdMETA BIOMED CO. LTD · META BIOMED CO., LTD | 7 | 2022–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | META BIOMED CO.LTDMeta Biomed Co., Ltd | 2 | — | 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 Meta Biomed Co, Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | ADSEALADSEAL PlusCeraPuttyCeraSealMetapasteMetapaste PlusMetapexMetapex PlusZenSealZenSeal disposable tips | 2007 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | EzfilJet Flow BulkMeta EtchantNexcompNexcomp Flow | 2008 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | MD-TempMD-Temp Plus | 2009 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Bar PlusGUTTA PERCHA CARTRIDGEGutta Percha Points and BarsSmart Fit GP | 1998 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | EQ CondenserEQ-V | 2015 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | AurumGL153 | 2015 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | EZ Bond UniversalMeta P&Bond | 2018 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | Jet Flow Bulk | 2024 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | — | 2025 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points | 1995 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | MD-ChelCreamMD-Cleanser | 2002 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | EQ-M | 2022 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2019 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Metacem | 2018 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | EQ-S | 2018 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | — | 2016 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | BoneMedik-DMRenew-Cera | 2009 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | BoneMedik-DMRenew-Cera | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Meta Biomed Co, Ltd as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Oct 2024 | K242014 | Jet Flow Bulk | EBF Resin Tooth Shade Material |
| 29 Sep 2023 | K232299 | CeraPutty | KIF Root Canal Filling Resin |
| 13 Apr 2023 | K230010 | ADSEAL Plus | KIF Root Canal Filling Resin |
| 3 Mar 2023 | K230009 | EZ Bond Universal | KLE Resin Tooth Bonding Agent |
| 30 Jun 2021 | K210904 | Metapaste Plus | KIF Root Canal Filling Resin |
| 14 Apr 2021 | K202617 | Metapex Plus | KIF Root Canal Filling Resin |
| 5 Mar 2020 | K191991 | Ezfil | EBF Resin Tooth Shade Material |
| 3 Jul 2019 | K190724 | MD-Temp Plus | EBG Resin Temporary Crown and Bridge |
| 7 Jun 2019 | K190503 | CeraSeal | KIF Root Canal Filling Resin |
| 29 May 2019 | K190510 | GuttaSil | KIF Root Canal Filling Resin |
| 15 Nov 2018 | K181689 | Nexcomp | EBF Resin Tooth Shade Material |
| 29 Aug 2018 | K180802 | Meta P&Bond | KLE Resin Tooth Bonding Agent |
| 15 May 2018 | K171449 | Metacem | EMA Dental Cement |
| 19 Sep 2014 | K133298 | ENDO SMART | EKX Ac-Powered Direct Drive Handpiece |
| 9 Apr 2014 | K134008 | MD-FLEX HEAVY BODY | ELW Impression Material |
| 31 Jul 2013 | K132041 | REXTAR X | EHD Extraoral with Timer X-Ray Unit |
| 1 Mar 2013 | K122016 | REXTAR, REXTAR LCD | EHD Extraoral with Timer X-Ray Unit |
| 5 Sep 2008 | K081913 | METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER | EMA Dental Cement |
| 3 Jun 2008 | K080772 | BONEMEDIK-DM | LYC Synthetic Bone Grafting Material |
| 7 Apr 2008 | K080305 | NEXCOMP AND META ETCHANT | EBF Resin Tooth Shade Material |
| 21 Jul 2006 | K061530 | MD-TEMP | EBG Resin Temporary Crown and Bridge |
| 24 Nov 2004 | K042769 | ADSEAL ROOT CANAL SEALER | KIF Root Canal Filling Resin |
| 8 Oct 2003 | K032605 | METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING | KIF Root Canal Filling Resin |
| 7 Oct 2003 | K032603 | METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING | KIF Root Canal Filling Resin |
Some of these clearances are listed with FDA today by another company: Sybron Dental Specialties (1), Poskom Co Ltd (1), Gebr. Brasseler GmbH & Co. KG (1), Coltene/Whaledent AG (1).
Also lists devices cleared under other names
Meta Biomed Co, Ltd lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Meta Systems Co., Ltd. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Oct 2025 | K253461 | Demi Pro | Meta Systems Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 21 Sep 2022 | K210475 | EQ-M | Meta Systems Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| META BIOMED CO., LTD.FDA reg. 9681254 | Cheongju-si Chungbuk, South Korea | Manufacturer, Private-label distributor |
| Meta Biomed, Inc.FDA reg. 3007301326 | Colmar, PA, United States | Repacker / relabeler |
| META SYSTEMS CO., LTD also doing business as S-Denti Co.,LtdFDA reg. 3007663058 | Seongnam-si Gyeonggi, South Korea | Manufacturer |
Other names on FDA records
META SYSTEMS CO., LTD. also doing business as S-Denti Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9021123, 10029431, 10027338). 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.