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Metapaste

EUDAMEDFDA 510(k)FDA UDI

Class IIa (EU MDR)

Ref -Model Metapaste510(k) K032605

by Meta Biomed Co., Ltd.

Identity

Trade Name
Metapaste EUDAMED
Metapaste(2 Syringe) FDA UDI
Metapaste(1 Syringe) FDA UDI
Generic Name
Endodontic temporary cement FDA UDI
Device Name
Calcium Hydroxide Temporary Filling Material EUDAMED
Metapaste is a biocompatible root canal sealer used for the temporary tilling of root canals after endodontic surgery. 2 Syringe(2.2g) FDA UDI
Metapaste is a biocompatible root canal sealer used for the temporary tilling of root canals after endodontic surgery. 1 Syringe(2.2g) FDA UDI
Model / Reference
Metapaste EUDAMED
- EUDAMED
9204 FDA UDI
9203 FDA UDI
Description
Metapaste is a biocompatible root canal sealer used for the temporary tilling of root canals after endodontic surgery. 2 Syringe(2.2g) FDA UDI
Metapaste is a biocompatible root canal sealer used for the temporary tilling of root canals after endodontic surgery. 1 Syringe(2.2g) FDA UDI

Identifiers

Primary DI / UDI-DI
08806387892052 EUDAMED
08806387893769 EUDAMED
08806387892045 EUDAMEDFDA UDI
08806387892038 EUDAMEDFDA UDI
Basic UDI-DI
B-08806387892052 EUDAMED
B-08806387893769 EUDAMED
B-08806387892038 EUDAMED
B-08806387892045 EUDAMED
510(k) Number
K032605 FDA 510(k)
FDA Product Code
KIF FDA 510(k)FDA UDI
EMDN Code
Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
GMDN Term
Endodontic temporary cement FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3820 FDA 510(k)
Regulation Number
872.3820 FDA 510(k)FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental coating, tooth-desensitizing

Metapaste by Meta Biomed Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental coating, tooth-desensitizing.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Meta Biomed Co., Ltd.
EUDAMED SRN
KR-MF-000009681
Authorised Representative
Meta Biomed Europe GmbH DE-AR-000004953

Sources (7)

  • EUDAMED cd5a9cb5-ff74-40a2-b0d1-893711f093d1 61 fields · synced Jul 21, 2026
  • EUDAMED 545f5f0e-0f50-4316-be08-7563db070ff0 61 fields · synced May 17, 2026
  • FDA 510(k) K032605 24 fields · synced May 18, 2026
  • FDA UDI ebfaef2a-55ea-4747-8afa-cf2a6a7bfde9 33 fields · synced May 30, 2026
  • FDA UDI f15d2aba-919a-46fc-bc94-3b124bb2f4a7 33 fields · synced May 30, 2026
  • EUDAMED 1c1ddc5c-9e1b-45bb-a2f8-3f14afcad0ea 61 fields · synced Jul 9, 2026
  • EUDAMED 254095cf-87f3-43ea-a06a-1257f2fb8acd 61 fields · synced Jul 21, 2026