FDA.report

RSVP Impression Trays Upper

Primary DI
D779505UPP1
Brand
RSVP Impression Trays Upper
Company
COSMEDENT, INC.
Model
505UPP
Published
2020-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EHYTray, Impression, Preformed

Product Code Classifications

CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D779505UPP1PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental impression tray, single-useA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
113911689
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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D7796722D21Bulkfill6722D22022-03-08
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D7796722A11Bulkfill6722A12022-03-01
D7796722A21Bulkfill6722A22022-03-01
D7796722A31Bulkfill6722A32022-03-01
D7796722B11Bulkfill6722B12022-03-01
D779203101116 Gauge Black Tips2031012021-11-11
D7792031021018 Gauge Pink Tips2031022021-11-11
D7792031031119 Gauge Silver Tips2031032021-11-11
D7792031041222 Gauge Black Tips2031042021-11-11
D77920320212Mixing Tips CosmeCore 8gTips2032022021-11-11
D77920320413MirrorImage 10:1 Tips2032042021-11-11
D77920320515Adhere 1:1 Tips2032052021-11-11
D77920320615Connect 4:1 Tips2032062021-11-11
D77920330211CosmeCore IntraOral Tips2033022021-11-11
D77920340213White Plastic Nozzle Tips2034022021-11-11
D77920350315CosmeCore 50g Tip Package2035032021-11-11
D77970351T1Impressiv 5:1 Putty Cartridge Tips70531T2021-11-11

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