DEVICE: CHEMFIL ROCK (D010606065901)

Device Identifier (DI) Information

CHEMFIL ROCK
60606590
In Commercial Distribution
60606590
Dentsply De Trey GmbH
D010606065901
HIBCC

1
315471722 *Terms of Use
CHEMFIL ROCK INTRO KIT is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting. The capsule extruder is used for the extrusion and direct application of the capsules. With its supporting accessory (Capsule Extruder) it can be classified as a convenience kit.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Glass ionomer dental cement A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
EBF MATERIAL, TOOTH SHADE, RESIN
EMA CEMENT, DENTAL
EBC SEALANT, PIT AND FISSURE, AND CONDITIONER
EJK LINER, CAVITY, CALCIUM HYDROXIDE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 4 and 28 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Weight: 442 Milligram
Total Volume: 0.12 Milliliter
Device Size Text, specify: Powder
Device Size Text, specify: Liquid
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Device Record Status

bc340f6d-c80f-437e-bb73-a3e8c064f968
March 29, 2018
2
September 20, 2016
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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)

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Yes
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None
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Production Identifier(s) in UDI

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No CLOSE

Customer Contact

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No Customer Contact currently defined
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