DEVICE: Guttacore Endodontic obturators and size verifier (J003GCP080261)

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Device Record History
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Device Identifier (DI) Information
Guttacore Endodontic obturators and size verifier
GCP08026
In Commercial Distribution
GCP08026
MAILLEFER INSTRUMENTS HOLDING Sàrl
J003GCP080261
HIBCC

1
480538495 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47751 Warm-bonded endodontic obturation system obturator
A hand-held manual dental instrument designed for direct warm bonding during an endodontic obturation procedure. It is preloaded (encased) with a resin-based sealing, filling, and core material at its distal working end which is subsequently heated in a dedicated oven to a specified temperature prior to delivery of the materials into a root canal. It is available in a variety of root canal sizes. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EKM GUTTA-PERCHA
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: up to 86°F
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
89ddf2c8-3870-4275-a9f9-22bdf21d3511
April 17, 2026
2
March 26, 2026
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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