Synapse Dental Pain Eraser-Professional Use

Primary DI
00303620002127
Brand
Synapse Dental Pain Eraser-Professional Use
Company
Septodont, Inc.
Model
01M0001
Device description
Synapse Dental Pain Eraser-Professional Use and Replacement Tips
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LWMDevice, Electrical Dental Anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWMDevice, Electrical Dental AnesthesiaUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193570000Dental Pain EraserSynapse Dental2020-01-17LWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00303620002127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00303620002127003036200021273036200021270303620002127

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation probeA non-sterile, hand-held, pen-like electrical conductor intended to be held against a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation]. It typically has a metallic tip for skin contact, sometimes using a conductive pad. This is a reusable device.

Regulatory Flags#

DUNS number
627058738
Device count
1
DM exempt
false
Premarket exempt
false
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
00303620002134Synapse Dental Pain Eraser-Home Use01M00022026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00303620002134Synapse Dental Pain Eraser-Home UseSeptodont, Inc.LWM2026-09-04