FDA.reportPublic FDA data

Sep-A-Rings Separators

Primary DI
00192029039120
Brand
Sep-A-Rings Separators
Company
TP ORTHODONTICS INC
Model
352-000
Device description
Original Small
Published
2021-02-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ECIBAND, ELASTIC, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192029039120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192029039120001920290391201920290391200192029039120

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic separatorA non-surgical orthodontic device typically in the form of a loop or ring intended to be placed between adjacent teeth to slowly move them apart to help achieve improved positioning and/or appearance of the teeth; it is not intended for separation of tooth roots. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005432299
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192029043264Foam Pellets150-7052023-10-05
00192029043271Bonding Accessories150-7142023-10-05
00192029043288Bonding Accessories150-9042023-10-05
00192029000199Light Cure Adhesive151-2722022-02-01
00192029000205Bonding Accessories150-0152022-02-01
00192029000212Bonding Accessories150-0202022-02-01
00192029000236Bonding Accessories150-7122022-02-01
00192029000250Bonding Accessories150-7152022-02-01
00192029000267Bonding Accessories150-8102022-02-01
00192029000083Light Cure Adhesive151-2702019-02-13
00192029000090Light Cure Adhesive151-2712019-02-13
00192029000106Light Cure Adhesive151-2732019-02-13
00192029050538Tip-Edge PLUS Stainless Steel Brackets296-61122025-02-04
00192029050545Tip-Edge PLUS Stainless Steel Brackets296-61222025-02-04
00192029050552Tip-Edge PLUS Stainless Steel Brackets296-61322025-02-04
00192029050569Tip-Edge PLUS Stainless Steel Brackets296-61422025-02-04
00192029050576Tip-Edge PLUS Stainless Steel Brackets296-61522025-02-04
00192029050583Tip-Edge PLUS Stainless Steel Brackets296-61622025-02-04
00192029050590Tip-Edge PLUS Stainless Steel Brackets296-61722025-02-04
00192029050606Tip-Edge PLUS Stainless Steel Brackets296-61822025-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456205020JMUJMU DENTAL, INCECI2026-06-22
00840456205037JMUJMU DENTAL, INCECI2026-06-22
00840456205044JMUJMU DENTAL, INCECI2026-06-22
00840456205051JMUJMU DENTAL, INCECI2026-06-22
00840456205068JMUJMU DENTAL, INCECI2026-06-22
00840456205075JMUJMU DENTAL, INCECI2026-06-22
00840456205082JMUJMU DENTAL, INCECI2026-06-22
00840456205099JMUJMU DENTAL, INCECI2026-06-22
00840456205105JMUJMU DENTAL, INCECI2026-06-22
00840456205112JMUJMU DENTAL, INCECI2026-06-22
00840456205129JMUJMU DENTAL, INCECI2026-06-22
00840456205136JMUJMU DENTAL, INCECI2026-06-22
00840456205143JMUJMU DENTAL, INCECI2026-06-22
00840456205150JMUJMU DENTAL, INCECI2026-06-22
00840456205167JMUJMU DENTAL, INCECI2026-06-22
00840456205174JMUJMU DENTAL, INCECI2026-06-22
00840456205181JMUJMU DENTAL, INCECI2026-06-22
00840456205198JMUJMU DENTAL, INCECI2026-06-22
00840456205204JMUJMU DENTAL, INCECI2026-06-22
00840456205211JMUJMU DENTAL, INCECI2026-06-22
00840456205228JMUJMU DENTAL, INCECI2026-06-22
00840456205235JMUJMU DENTAL, INCECI2026-06-22
00840456205242JMUJMU DENTAL, INCECI2026-06-22
00840456205259JMUJMU DENTAL, INCECI2026-06-22
00840456205426JMUJMU DENTAL, INCECI2026-06-22
00840456205433JMUJMU DENTAL, INCECI2026-06-22
00840456205440JMUJMU DENTAL, INCECI2026-06-22
00840456205457JMUJMU DENTAL, INCECI2026-06-22
00840456205464JMUJMU DENTAL, INCECI2026-06-22
00840456205471JMUJMU DENTAL, INCECI2026-06-22