DEVICE: Etchmaster (D798EMTRS1)

Device Identifier (DI) Information

Etchmaster
EMTRS
In Commercial Distribution
EMTRS
RELIANCE ORTHODONTIC PRODUCTS INC
D798EMTRS1
HIBCC

25
113170088 *Terms of Use
The Etchmaster system is intended for use for polishing, roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures. This is the Etchmaster Regular Small Tips
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Dental abrasive air jet system An assembly of devices that together comprise a dental abrasive air jet system used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth or teeth. It typically consists of a control unit, a dedicated handpiece and a foot switch that enables the dentist to control the abrasion process. It has a wide variety of applications such as, the removal of plaque and stains, cleaning fissures (above and below the gingival), the preparation of the tooth surface prior to bonding, the cleaning of orthodontic appliances (bands and brackets), the removal of adhesive residue and the cleaning of implants prior to loading.
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FDA Product Code

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Product Code Product Code Name
KOJ Airbrush
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K030292 000
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

f41ecca8-1f20-4075-82d0-cea22f2f98f8
July 06, 2018
3
September 04, 2016
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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
D798EMTRS2 50 D798EMTRS1 In Commercial Distribution Bag
D798EMTRS3 100 D798EMTRS1 2017-12-21 Not in Commercial Distribution Bag
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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: D798EMTRS0 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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