FDA.reportPublic FDA data

Safco Ellipses Swivel Couplers

Primary DI
00810063750664
Brand
Safco Ellipses Swivel Couplers
Company
SAFCO DENTAL SUPPLY CO.
Model
1022898
Catalog number
1022898
Device description
Safco Ellipses swivel couplers, 6 pin, LED
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EFBHandpiece, air-powered, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810063750664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810063750664008100637506648100637506640810063750664

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic dental handpiece couplerA short connecting device intended to couple a pneumatic dental handpiece (e.g., a dental high-speed drill handpiece, dental restorative material sonic handpiece) and the hose that connects to the dental delivery system or a control unit, to provide the operator full rotational freedom of movement of the handpiece. This device contains a swivel mechanism that allows the freedom of movement. This is a reusable device.

Regulatory Flags#

DUNS number
020417380
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D72310203523Prep&Etch™102-0352102-03522016-08-17
D72310203603Prep&Etch™102-0360102-03602016-08-17
D72310202123Safco TruCheck102021210202122022-06-17
D72310202133Safco TruCheck102021310202132023-07-31
D72310202153Safco TruCheck102021510202152022-06-17
D72310202173Safco TruCheck102021710202172022-06-17
D72310202183Safco TruCheck102021810202182023-07-31
D72310202193Safco TruCheck102021910202192022-06-17
D72310202213Safco TruCheck102022110202212022-06-17
D72310224053Safco Pure102240510224052022-03-30
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10810063756250Power Curve Toothbrush82500830022025-03-19
10810063756267Esprit Ultra Fine Toothbrush82500872082025-03-19
10810063756274Whisper Tech Ultra-Fine Toothbrush82500926012025-03-19
10810063756281Power Curve Toothbrush8250093002-I2025-03-19
10810063756403Power Curve Extra-Soft Toothbrush8250094002XS2025-03-19
10810063756434KIDS BUDDY Toothbrush8250072TK3-I2025-03-19
10810063756588Jr Series Comfort Grip Toothbrush82500892402025-03-19
10810063756595Power Curve Extra-Soft Toothbrush8250095002XS-I2025-03-19
20810063756240KIDS BUDDY Toothbrush8250071TK32025-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D7022666550StarDentalDENTALEZ, INC.EFB2026-09-18
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D950133852360Xtreme PowerLARES RESEARCHEFB2026-09-04
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D950133922360Xtreme PowerLARES RESEARCHEFB2026-09-04
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D950134812360Xtreme PowerLARES RESEARCHEFB2026-09-04
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D950134912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134942360Xtreme PowerLARES RESEARCHEFB2026-09-04
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