EUDAMED last updated this device on Jul 22, 2026

Becht Gutta Percha Points

B-08806387802129

On the marketClass IIa

Applicable legislation: —
Organization name: META BIOMED CO., LTD.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08806387802129
Reference / catalog number: -

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

Becht Gutta Percha Points is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by META BIOMED CO., LTD.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Becht Gutta Percha Points
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08806387802129
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-08806387802129
Reference / catalog number: -
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: "Gutta Percha Points-S are root canal obturation material. It is used to fill the cleaned, shaped and irrigated root canal space. - Time saving with easy filling - For faster and easier root canal obturation - Variable tapers & sizes - Length marking available - Excellent radiopacity - Long shelf life and freshness assured - Suitable for vertical and lateral condensation - Physically soft material - Benefits for curved root canal filling"
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08806387802129

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q01010203DENTAL CONES

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

Caution
"1.1 This product is designed to be used only for oral tissues. Please be careful to avoid eye contact. In the event of eye contact, wash the contacted eye immediately and then consult a doctor. 1.2 Non-specialists are prohibited from using this product. Do not use this product for any purposes other than its intended purposes. 1.3 Do not prescribe an internal medicine."
"2. Warnings 2.1 Do not use this product for any patients with a history of hypersensitivity reactions to it, such as a rash, dermatitis, etc. 2.2 Some patients have an allergic reaction to Trans 1,4 Polyisoprene materials and/or even experience hypersensitivity. Do not use this product for them. 3. Points of Caution for Application 3.1 Should be careful to avoid overfilling or dead space. 3.2 Be sure to take measures for the protection of the respiratory tract before."
OTHER

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jun 30, 2003	Still on market

Becht Gutta Percha Points

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UDI-DI DataMatrix

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Lifecycle

Market distribution

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Device identification

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Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

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Safety

Regulatory

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Certificates

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