FDA.reportPublic FDA data

DELTAGLACE

Primary DI
EDEL13700300
Brand
DELTAGLACE
Company
DeltaMed GmbH
Model
1370030
Catalog number
1370030
Device description
DELTAGLACE, Bottle 10ml
Published
2023-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030832000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030832000PRIMOSPLINT SYSTEMCosmedent, Inc.2003-09-17MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDEL13700300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental occlusal splint, custom-madeA rigid or flexible custom-made appliance that overlays the occlusal surfaces of the teeth. It is used to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00avoid direct sunlight
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344805101
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDEL6051070Insure® Lite6051076051072023-06-12
EDEL6021080Insure® 6021086021082023-06-05
04260635980481RS Surgical GuideRS001533RS0015332022-02-11
04260635980542RS Try-InRS001535RS0015352022-02-11
04260635981556PRO Resins Guide X019.3054019.30542026-01-26
EDEL6021010Insure® 6021016021012023-06-05
EDEL6021050Insure® 6021056021052023-06-05
04260635981570RS VIVO GuideRS006196RS0061962025-11-24
EDEL160526003Delta Guide XT160526016052602025-11-24
EDEL6051010Insure® Lite6051016051012023-06-05
EDEL6051020Insure® Lite6051026051022023-06-12
EDEL605ACL0Insure® Lite Automix605ACL605ACL2023-06-12
EDEL6021020Insure® 6021026021022023-06-05
EDEL160511003Delta Splint160511016051102022-02-11
EDEL160524003Delta Guide S160524016052402022-02-11
EDEL162112003Delta Try-In162112016211202022-01-31
04260635981587RS VIVO TrayRS006198RS0061982025-07-29
04260635981594RS VIVO Try-InRS006199RS0061992025-07-29
EDEL162112103Delta Try-In XT162112116211212025-07-29
EDEL162162003Delta Tray Rose162162016216202025-07-29

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00190730084590Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
H66842000141KeyPrintKeystone IndustriesMQC2024-09-26
H66841101411KeyPrintKeystone IndustriesMQC2023-09-25
H66842201511KeyPrintKeystone IndustriesMQC2023-09-25
EPRCD1001501printodent GR-19.1 OApro3dure medical GmbHMQC2023-08-29
EPRCD1001504printodent GR-19.1 OA I MSIpro3dure medical GmbHMQC2023-08-29
D745701164RSN00070Glidewell TuffSplint™ Appliance ResinPrismatik Dentalcraft, IncMQC2023-04-11
00810002220241The Luco Hybrid OSA ApplianceJOHN'S DENTAL LABORATORY INCMQC2023-03-28
H66842000111KeyPrintKeystone IndustriesMQC2023-02-20
H66842001611KeyPrintKeystone IndustriesMQC2023-02-20
H66842200111KeyPrintKeystone IndustriesMQC2023-02-20
H66842201141HeyGearsKeystone IndustriesMQC2023-02-20
H66842201611KeyPrintKeystone IndustriesMQC2023-02-20
H66850524011Nexa3DKeystone IndustriesMQC2023-02-20
H66852233011Nexa3DKeystone IndustriesMQC2023-02-20
H668D6400231PearsonKeystone IndustriesMQC2023-02-20
H668D6400241PearsonKeystone IndustriesMQC2023-02-20
H668D6400271PearsonKeystone IndustriesMQC2023-02-20
H668210041American DentalKeystone IndustriesMQC2022-11-30
H668210051American DentalKeystone IndustriesMQC2022-11-30
H668210061American DentalKeystone IndustriesMQC2022-11-30
H66870001901ProformKeystone IndustriesMQC2022-11-30
H6687000190R11ProformKeystone IndustriesMQC2022-11-30
H6687000190R21ProformKeystone IndustriesMQC2022-11-30
H66870001911ProformKeystone IndustriesMQC2022-11-30
H6687000191R11ProformKeystone IndustriesMQC2022-11-30
H6687000191R21ProformKeystone IndustriesMQC2022-11-30
H66870001921ProformKeystone IndustriesMQC2022-11-30