FDA.report

e-Space Maintainer

Primary DI
08906154841198
Brand
e-Space Maintainer
Company
KIDS-E-DENTAL LLP
Model
SM-35
Device description
e - Space Maintainer Band Size 35, Refill-1 Band
Published
2026-05-26
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
true

Related Records

Product Codes

CodeName
DYTMaintainer, Space Preformed, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
DYTMaintainer, Space Preformed, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08906154841198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08906154841198089061548411988906154841198

GMDN Terms

TermDefinition
Orthodontic space maintainerA dental prosthetic replacement for prematurely lost deciduous teeth intended to prevent closure of the space before eruption of the permanent successors. It is often an urgent necessity in the buccal segment to prevent impaction of the permanent teeth and other complications.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
861296265
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08906154840993e-Space MaintainerSM-252026-05-26
08906154841006e-Space MaintainerSM-25.52026-05-26
08906154841013e-Space MaintainerSM-262026-05-26
08906154841020e-Space MaintainerSM-26.52026-05-26
08906154841037e-Space MaintainerSM-272026-05-26
08906154841044e-Space MaintainerSM-27.52026-05-26
08906154841051e-Space MaintainerSM-282026-05-26
08906154841068e-Space MaintainerSM-28.52026-05-26
08906154841075e-Space MaintainerSM-292026-05-26
08906154841082e-Space MaintainerSM-29.52026-05-26
08906154841099e-Space MaintainerSM-302026-05-26
08906154841105e-Space MaintainerSM-30.52026-05-26
08906154841112e-Space MaintainerSM-312026-05-26
08906154841129e-Space MaintainerSM-31.52026-05-26
08906154841136e-Space MaintainerSM-322026-05-26
08906154841143e-Space MaintainerSM-32.52026-05-26
08906154841150e-Space MaintainerSM-332026-05-26
08906154841167e-Space MaintainerSM-33.52026-05-26
08906154841174e-Space MaintainerSM-342026-05-26
08906154841181e-Space MaintainerSM-34.52026-05-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08906154840993e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841006e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841013e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841020e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841037e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841044e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841051e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841068e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841075e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841082e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841099e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841105e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841112e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841129e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841136e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841143e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841150e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841167e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841174e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841181e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841204e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841211e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841228e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841235e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841242e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841259e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841266e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841273e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841280e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841297e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26