FDA.report

Safco One Tray Impression Trays

Primary DI
D72310230320
Brand
Safco One Tray Impression Trays
Company
SAFCO DENTAL SUPPLY CO.
Model
1023032
Catalog number
1023032
Device description
Safco One Tray impression trays, #4 medium lower, 12/bag
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
EBHMATERIAL, IMPRESSION TRAY, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D72310230323PrimaryHIBCC0
D72310230320Unit of UseHIBCC0

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
020417380
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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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