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Sign in to claim this brandWhat Meta Biomed, Inc. makes
Meta Biomed, Inc. manufactures endodontic paper points, synthetic gutta-percha, rotary and reciprocating endodontic files and rasps, dental composite resins, animal-derived dental bone matrix implants, endodontic temporary cements, tungsten-weighted oesophageal dilators, and hygroscopic dental cements.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA's Global Unique Device Identification Database (GUDID). Meta Biomed, Inc. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Meta Biomed, Inc. manufacture?
Meta Biomed, Inc. manufactures endodontic paper points, synthetic gutta-percha, rotary and reciprocating endodontic files and rasps, dental composite resins, animal-derived dental bone matrix implants, endodontic temporary cements, tungsten-weighted oesophageal dilators, and hygroscopic dental cements. These products are listed in the device categories provided, and the company does not produce any other types of devices beyond those specified in the data.
Where is Meta Biomed, Inc. based?
Meta Biomed, Inc. is based in the United States, as explicitly stated in the SUMMARY section of the device data. The COUNTRY field confirms this location, and no other geographic details about the company's headquarters or facilities are provided or implied.
In which regulatory registry are Meta Biomed, Inc.'s devices listed?
Meta Biomed, Inc.'s devices are listed in the FDA's Global Unique Device Identification Database (GUDID), which is referenced in the LISTED IN field as 'fda_udi' and confirmed in the SUMMARY. This registry is used for tracking medical devices in the U.S. market, and the company's inclusion there does not imply approval or clearance of any device.
How are Meta Biomed, Inc.'s devices classified under regulatory frameworks?
Meta Biomed, Inc.'s devices are classified as Class I and Class II medical devices, as stated in the DEVICE CLASSES field and reiterated in the SUMMARY. This classification reflects the level of regulatory control required, with Class I being low risk and Class II requiring special controls, but it does not indicate that the company itself is approved or cleared.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 3015 Advance Lane, Colmar, PA, 18915
- Website
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- —
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3007301326
- DUNS Number
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Catalogue (1582)
Page 9 of 32| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BoneMedik, 10X10X10mm | 9500 | FDA UDI | Class II | Unknown |
| GuttaSil Refill | 9411 | FDA UDI | Class I | Unknown |
| Gutta Percha 02-LM-120 | 0443 | EUDAMEDFDA UDI | Class I | Active |
| Gutta Percha 02-LM-10 | 0919 | FDA UDI | Class I | Active |
| Absorbant Paper Points, 25 | 2379 | FDA UDI | Class I | Active |
| Gutta Percha 02-25 | 0686 | FDA UDI | Class I | Active |
| Absorbant Paper Points, 55 | 2726 | FDA UDI | Class I | Active |
| Absorbant Paper Points, 04-40 | 2778 | FDA UDI | Class I | Active |
| Gutta Percha LM-R-F | 0739 | EUDAMEDFDA UDI | Class I | Active |
| Absorbant Paper Points, 45 | 2383 | FDA UDI | Class I | Active |
| Metapex 0.8 | 9325 | FDA UDI | Class II | Active |
| Gutta Percha 04-30 | 0748 | FDA UDI | Class I | Active |
| Absorbant Paper Points, 04-80 | 2784 | FDA UDI | Class I | Active |
| Gutta Percha 04-15 | 0580 | FDA UDI | Class I | Active |
| Mx 06-15/40 | 1498 | FDA UDI | Class I | Active |
| Gutta Percha 04-LM-15/40 | 0785 | FDA UDI | Class I | Active |
| BoneMedik, 12X12X25mm | 9504 | FDA UDI | Class II | Unknown |
| Absorbant Paper Points, 30 | 2499 | FDA UDI | Class I | Active |
| Aurum (Blue T2.5 Refill 31mm) | 5093 | FDA UDI | Class I | Active |
| Absorbent Paper Points, LM-45/80 | 2647 | FDA UDI | Class I | Active |
| Mg 04-40 Lm | 1489 | FDA UDI | Class I | Active |
| Aurum Blue T1 Absorbent Paper Points, LM-04-20 | 2558 | FDA UDI | Class I | Active |
| Absorbent Paper Points, 04-30 | 2664 | FDA UDI | Class I | Active |
| Absorbent Paper Points, 06-35 | 2575 | FDA UDI | Class I | Active |
| Absorbent Paper Points, 06-LM-20 | 2475 | FDA UDI | Class I | Active |
| Gutta Percha LM-F2 | 0548 | FDA UDI | Class I | Active |
| Gutta Percha 06-LM-45/80 | 0638 | FDA UDI | Class I | Active |
| Gutta Percha 04-10 | 0467 | EUDAMEDFDA UDI | Class I | Active |
| Absorbent Paper Points, 06-LM-25 | 2476 | FDA UDI | Class I | Active |
| Aurum Pro Absorbent Paper Points, F4 | 2368 | FDA UDI | Class I | Active |
| Gutta Percha R-XL | 0853 | FDA UDI | Class I | Active |
| Absorbent Paper Points, 06-45/80 | 2800 | FDA UDI | Class I | Active |
| Nexcomp Flow intro Kit | 6000 | FDA UDI | Class II | Active |
| BoneMedik-DM, 2~4mm, 1g | 9726 | FDA UDI | Class II | Active |
| Absorbent Paper Points, 90/140 | 2397 | FDA UDI | Class I | Active |
| Absorbent Paper Points, 08-20 | 2346 | FDA UDI | Class I | Active |
| Absorbent Paper Points, NC 110 | 2592 | FDA UDI | Class I | Active |
| Gutta Percha 06-25 | 0555 | EUDAMEDFDA UDI | Class I | Active |
| Gutta Percha 04-45 | 0751 | FDA UDI | Class I | Active |
| Absorbent Paper Points, 08-35 | 2349 | FDA UDI | Class I | Active |
| Absorbent Paper Points, LM-70 | 2409 | FDA UDI | Class I | Active |
| Mg 04-15 Lm | 1484 | FDA UDI | Class I | Active |
| E&Q Master / Gun needle set [25G] | 9034 | FDA UDI | Class I | Unknown |
| Absorbent Paper Points, 06-60 | 2796 | FDA UDI | Class I | Active |
| BoneMedik-DM, 2~4mm, 0.5cc | 9755 | FDA UDI | Class II | Active |
| Gutta Percha 06-LM-25 | 0789 | FDA UDI | Class I | Active |
| BoneMedik, 2~4mm, 30cc | 9526 | FDA UDI | Class II | Unknown |
| Gutta Percha 04-60 | 0754 | EUDAMEDFDA UDI | Class I | Active |
| Gutta Percha 04-LM-50 | 0617 | FDA UDI | Class I | Active |
| Absorbent Paper Points, XF | 2540 | FDA UDI | Class I | Active |
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