FDA.reportPublic FDA data

Quick Seal

Primary DI
07290115053340
Brand
Quick Seal
Company
B.J.M. LABORATORIES LTD
Model
100130
Published
2026-03-13
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
false

Product Codes#

Code, Name table
CodeName
EBCSEALANT, PIT AND FISSURE, AND CONDITIONER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061997000PREMIER SELF-ETCHING ENAMEL SEALANTPremier Dental Products Co.2006-10-04EBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115050356PrimaryGS10
07290115053340Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115050356072901150503567290115050356
07290115053340072901150533407290115053340

GMDN Terms#

Term, Definition table
TermDefinition
Dental unfilled resin sealant/coatingA non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1.2Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature024 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514764117
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
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
07290115050400High-Q-Bond SE100050SE2026-03-20
07290115050523BJM Root Canal Sealer4002002026-03-20
07290115050356Quick Seal1001302026-03-13
07290115050035High-Q-Bond Bracket Adhesive4000632026-03-13
07290115050196Prima Quick Prime1002102026-03-13
07290115051889Smile Stream STEP-1 PumEtch9000-10002026-03-13
07290115051896Ideal 1 Orthodontic Bracket Adhesive52-800-102026-03-13
07290115051902High-Q-Bond Band4000662026-03-13
07290115050141Multi Bond1000462023-11-22
07290115050158Multi Bond1000472023-11-22
07290115052886Auto-Cure Activator1000602023-11-22
07290115050370High-Q-Bond Adhesive Resin Cement Automix100050AM2023-11-22
07290115050448Porcelain Fix4000842023-11-22
07290115050462Porcelain Silane4000832023-11-22
07290115050479Porcelain Etch4000822023-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810000525799Predicta®PARKELL, INC.EBC2026-09-25
10810000525802Predicta®PARKELL, INC.EBC2026-09-25
306058610660213M™ Clinpro™3M COMPANYEBC2026-04-17
306058610660833M™ Clinpro™3M COMPANYEBC2026-04-17
07899633835232Vittra APS Unique FlowDentscare LtdaEBC2024-11-26
08806387860044Jet Flow Bulk UniversalMeta Biomed Co., Ltd.EBC2024-11-16
08806387860051Jet Flow Bulk A1Meta Biomed Co., Ltd.EBC2024-11-16
08806387860068Jet Flow Bulk A2Meta Biomed Co., Ltd.EBC2024-11-16
08806387860075Jet Flow Bulk A3Meta Biomed Co., Ltd.EBC2024-11-16
08806387860136Jet Flow Bulk DentinMeta Biomed Co., Ltd.EBC2024-11-16
D77819950611Scott's Select ColorFil Flow Single-Shade PrismaticSCOTT'S DENTAL SUPPLY L.L.C.EBC2024-08-27
D77819950631Scott's Select ColorFil Flow BlockerSCOTT'S DENTAL SUPPLY L.L.C.EBC2024-08-27
07615208294187Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208294194Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208294200Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208294217Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208301335Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2023-04-06
H6686050011iSmileHarry J Bosworth CompanyEBC2023-02-20
306058610689263M™ Clinpro™3M COMPANYEBC2022-12-08
00810111542418OpaquerBISCO INC.EBC2022-10-11
00810111540629Choice 2BISCO INC.EBC2022-10-11
00810111540612Choice 2BISCO INC.EBC2022-10-10
00810111540872Duo-Link UniversalBISCO INC.EBC2022-10-10
00810111542302eCementBISCO INC.EBC2022-10-10
00810111542319eCementBISCO INC.EBC2022-10-10
00810111540117Porcelain PrimerBISCO INC.EBC2022-09-30
00810111540605Choice 2BISCO INC.EBC2022-08-02
D79645420MARK3CARGUS INTERNATIONAL, INCEBC2021-07-01
D757C3900KEU1Choice 2BISCO INC.EBC2021-06-25
D757C52410KEU1eCementBISCO INC.EBC2021-06-25