FDA.reportPublic FDA data

Safco Nice Bite Dual Arch Bite Trays

Primary DI
D72310253620
Brand
Safco Nice Bite Dual Arch Bite Trays
Company
SAFCO DENTAL SUPPLY CO.
Model
1025362
Catalog number
1025362
Device description
Safco Nice Bite™ dual arch bite trays sideless 48/box
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
D72310253623PrimaryHIBCC0
D72310253620Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
020417380
Device count
48
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20810063756240KIDS BUDDY Toothbrush8250071TK32025-03-19
20810063756257Power Curve Toothbrush82500830022025-03-19
20810063756264Esprit Ultra Fine Toothbrush82500872082025-03-19
20810063756271Whisper Tech Ultra-Fine Toothbrush82500926012025-03-19
20810063756288Power Curve Toothbrush8250093002-I2025-03-19
20810063756400Power Curve Extra-Soft Toothbrush8250094002XS2025-03-19
20810063756431KIDS BUDDY Toothbrush8250072TK3-I2025-03-19
20810063756585Jr Series Comfort Grip Toothbrush82500892402025-03-19
20810063756592Power Curve Extra-Soft Toothbrush8250095002XS-I2025-03-19
20810063755564Waxed Dental Floss8250016300062025-03-18
20810063756172Euro Tech Compact Sensitive Toothbrush8250007T1872025-03-18
20810063756189Waxed Dental Floss8250017300072025-03-18
20810063756196Floss Picks8250039FP2025-03-18
20810063756202Endeavor Toothbrush8250043T0202025-03-18
20810063756219Vital Fresh Toothbrush8250048T056-I2025-03-18
20810063756226Aspire Compact Toothbrush8250060T509-I2025-03-18
20810063756233PlaquePRO Interdental Proxy Brush8250066T5132025-03-18
20810063756394Polisher Compact Toothbrush8250058T4902025-03-18
20810063756530Soft Flex Toothbrush8250054T183-I2025-03-18
20810063756547Glisten Junior Toothbrush8250064T511-I2025-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00723896030325ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030356ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030387ECOsply™ Biodegradable Disposable Impression Trays Medium Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030417ECOsply™ Biodegradable Disposable Impression Trays Small Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030448ECOsply™ Biodegradable Disposable Impression Trays Small Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030479ECOsply™ Biodegradable Disposable Impression Trays Quadrant UR/LL 10/PackPRACTICON, INC.EHY2026-01-08
00723896030509ECOsply™ Biodegradable Disposable Impression Trays Quadrant UL/LR 10/PackPRACTICON, INC.EHY2026-01-08
00723896030530ECOsply™ Biodegradable Disposable Impression Trays Anterior Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030561ECOsply™ Biodegradable Disposable Impression Trays Anterior Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030592ECOsply™ Biodegradable Disposable Impression Trays Assortment 10/PackPRACTICON, INC.EHY2026-01-08
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