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GuttaSil Refill

FDA UDI

Class I (US FDA UDI)

by Meta Biomed, Inc.

Identity

Trade Name
GuttaSil Refill FDA UDI
Generic Name
Hygroscopic dental cement FDA UDI
Device Name
GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads. FDA UDI
Model / Reference
9411 FDA UDI
Description
GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads. FDA UDI

Identifiers

Primary DI / UDI-DI
08806387894117 FDA UDI
510(k) Number
K190510 FDA UDI
FDA Product Code
EKM FDA UDI
KIF FDA UDI
GMDN Term
Hygroscopic dental cement FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3850 FDA UDI
872.3820 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

GuttaSil Refill by Meta Biomed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meta Biomed, Inc.

Sources (1)

  • FDA UDI 9d6f0d62-cebb-448a-8d46-f914419b31f8 35 fields · synced May 30, 2026