DEVICE: CHEMFIL ROCK (D010606065911)

Device Identifier (DI) Information

CHEMFIL ROCK
60606591
In Commercial Distribution
60606591
Dentsply De Trey GmbH
D010606065911
HIBCC

50
315471722 *Terms of Use
CHEMFIL ROCK A1 REFILL is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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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
EMA CEMENT, DENTAL
EBF MATERIAL, TOOTH SHADE, RESIN
EJK LINER, CAVITY, CALCIUM HYDROXIDE
EBC SEALANT, PIT AND FISSURE, AND CONDITIONER
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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
Device Size Text, specify: Liquid
Total Volume: 0.12 Milliliter
Weight: 442 Milligram
Device Size Text, specify: Powder
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Device Record Status

6c261840-981a-482a-8a88-1678c308ee10
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: D010606065910 CLOSE

Direct Marking (DM)

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No
None
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Production Identifier(s) in UDI

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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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