FDA.report

Mixing well

Primary DI
D7981SEPW0
Brand
Mixing well
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
1SEPW
Catalog number
1SEPW
Device description
MIXING WELL for SEP System. Light Impervious well.
Published
2016-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ECPInstrument, Ligature Tucking, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
ECPInstrument, Ligature Tucking, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7981SEPW0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dappen dish, single-useA small, shallow concave vessel made of a thermoplastic material used to mix dental materials chairside prior to application to the patient during dental procedures. The device is typically placed in a holder while the user dispenses the required amount of component materials into it and mixes them by hand (e.g., with a spatula) until the consistency of the mixture is appropriate. The device will then be placed in a hand-held holder for patient application. It is most often used for prophy and fluoride treatments, for mixing composite materials, acrylics, cements, and amalgams. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
6307734009PAULGROPI@AOL.COM

Regulatory Flags

DUNS number
113170088
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00840479203287MIXING RESERVOIR RING WELRWSAM2026-03-12
00840479203294RELIAMOLDSRMK2026-03-12
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00840479203355SAFETY GLASSESSG2026-03-12
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00840479203379BOND A BRAID 6 INCH LINGUAL RETAINER WIRESSAMBAB22026-03-12
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