FDA.reportPublic FDA data

SoftWedge™

Primary DI
20810038093387
Brand
SoftWedge™
Company
GARRISON DENTAL SOLUTIONS, L.L.C.
Model
WDYL
Catalog number
WDYL
Device description
Wedge Refill, X-Small, Yellow
Published
2020-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810038093387PrimaryGS10
00810038093383Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081003809338720810038093387
00810038093383008100380933838100380933830810038093383

GMDN Terms#

Term, Definition table
TermDefinition
Dental wedge, single-useA small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure. It is typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or rubber dam). It may include a removable shield intended to protect the healthy tooth/teeth from damage by the instruments. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-437-0032gds@garrisondental.com

Regulatory Flags#

DUNS number
057647005
Device count
300
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810038091464LOOP™ LED Curing LightCLK01-RCLK01-R2025-02-27
00810038091471LOOP™ LED Curing LightCLK01-WCLK01-W2025-02-27
00810038091488LOOP™ LED Curing LightCLK01-SCLK01-S2025-02-27
00810038091129Quad Matrix System™QPLQPL2025-02-16
00810038091136Quad Matrix System™QK4-MQK4-M2025-02-16
00810038091143Quad Matrix System™QK4QK42025-02-16
00810038091150Quad Matrix System™QBLQBL2025-02-16
00810038091167Quad Matrix System™QORQOR2025-02-16
00810038091174Quad Matrix System™QGRQGR2025-02-16
00810038091181Quad Matrix System™QPL-MQPL-M2025-02-16
00810038091198Quad Matrix System™QBL-MQBL-M2025-02-16
00810038091204Quad Matrix System™QOR-MQOR-M2025-02-16
00810038091211Quad Matrix System™QGR-MQGR-M2025-02-16
00810038091228Quad Matrix System™QR01QR012025-02-16
00810038091235Quad Matrix System™Q400Q4002025-02-16
00810038091242Quad Matrix System™Q500Q5002025-02-16
00810038091259Quad Matrix System™Q400L-1Q400L-12025-02-16
00810038091266Quad Matrix System™Q400R-1Q400R-12025-02-16
00810038091273Quad Matrix System™Q500L-1Q500L-12025-02-16
00810038091280Quad Matrix System™Q500R-1Q500R-12025-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955BBGA351Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA451Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA551Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA701Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BONDNG1Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
00810226102231AiraAIRA, LLCDZN2026-08-26
00810226102248AiraAIRA, LLCDZN2026-08-26
00198506092688ELMED INCORPORATEDELMED INCORPORATEDDZN2026-07-28
E0HM39MI2071Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
E0HM39MI2081Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
00190776403867MillenniumAvalign Technologies, Inc.DZN2026-07-21
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29