FDA.reportPublic FDA data

Impression Trays Perforated

Primary DI
G429A4290
Brand
Impression Trays Perforated
Company
MEED SKILL SURGICAL
Model
A429
Device description
Impression trays are dental instruments which are used to hold the Impression material in place to take a Impression of the tissue surfaces in the oral cavity, the impression trays are mainly used in Prosthodontics and used in Orthodontics to take impression of the Dentulous teeth.
Published
2023-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EHYTray, Impression, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G429A4290PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"

Regulatory Flags#

DUNS number
645670493
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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G429MSS71023A0Semkin Taylor forceps surgical straight 13CMMSS71023AMSS71023A2023-02-24
G429MSS820160Stainless steel bowl small 6CMMSS82016MSS820162023-03-03
G429MSS820140Stainless steel bowl large 10CMMSS820164MSS820162023-03-03
G429MSS820150Stainless steel bowl medium 8CMMSS82015MSS820152023-03-03
G429MSS820170Allis Tissue Forceps 3:4 teeth,160mmMSS82017MSS820172023-02-25
G429MSS820180Gross Maier dressing forceps straight XL 25CMMSS82018MSS820182023-02-25
G429MSS820190Gross Maier dressing forceps 16CMMSS82019MSS820192023-02-25
G429MSS820200Allis Tissue Forceps 160mmMSS82020MSS820202023-02-25
G429MSS820210Micro Suction Tube Green 86 x 2.1mm ODMSS82021MSS820212023-02-25

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Primary DI, Brand, Company table
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