DEVICE: Bosworth Trusoft (H66809212441)

Device Identifier (DI) Information

Bosworth Trusoft
0921244
In Commercial Distribution
0921244
Harry J Bosworth Company
H66809212441
HIBCC

1
014769301 *Terms of Use
25 lb Trusoft PEMA Powder
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
17610 Denture reliner, soft, professional
A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EBI RESIN, DENTURE, RELINING, REPAIRING, REBASING
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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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from moisture
Special Storage Condition, Specify: Keep out of direct sunlight
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Clinically Relevant Size

[?]
Size Type Text
Weight: 25 Pound
Weight: 11.34 Kilogram
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Device Record Status

f7cdd82f-515d-4a06-918a-48d0b9071c3f
March 29, 2018
2
May 15, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)333-3131 8455
tschwear@keystoneind.com
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