FDA.report

APOLLO DI SpeedSpray

Primary DI
E27664145722
Brand
APOLLO DI SpeedSpray
Company
SIRONA Dental Systems GmbH
Model
6414572
Device description
APOLLO DI SpeedSpray
Published
2016-09-10
Public version status
Update
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

Contact Domains

Product Codes

CodeName
ELWMaterial, Impression

Product Code Classifications

CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E27664145722PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental impression tray, single-useA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius51 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+4962511670contact@dentsplysirona.com

Regulatory Flags

DUNS number
340306351
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
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 DIBrandModelCatalogPublished
E27668665320Midwest IMPLANT 20:168665322026-02-19
E27668312130Midwest Motor Control Module683121368312132026-02-17
E27668234260Primevision 3D675859867585982026-02-13
E27668302980Midwest Power Lux Implant Motor683029868302982026-02-13
E27668303060Midwest Power Lux Motor683030668303062026-02-13
E27665716860SiroLaser65716862025-09-03
E27662122080Motor BL implant62122082025-08-20
E27668534800CAD/CAM Software68534802025-08-19
E2766802040Primescan 2680204068020402025-05-16
E27668020400Primescan 2680204068020402025-05-16
E27668053650Primescan 2 Multiuse Sleeve680536568053652025-05-06
E27668325750TiBase683257568325752025-05-06
E27668325830TiBase683258368325832025-05-06
E27668326090TiBase683260968326092025-05-06
E27668326170TiBase683261768326172025-05-06
E27668326250TiBase683262568326252025-05-06
E27668326330TiBase683263368326332025-05-06
E27668326580TiBase683265868326582025-05-06
E27668326660TiBase683266668326662025-05-06
E27668004570Primescan 2 Cart680045768004572025-03-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850078989369SmileSet Impression Kit - RetainerOrtho Dental Lab LLCELW2026-03-20
00850078989376SmileSet Impression Kit - Night GuardOrtho Dental Lab LLCELW2026-03-20
00860014754630Owl Impression KitOWL DENTAL LAB INCELW2026-03-05
E241AA9050Cavex CleverCast - Slow SetCavex Holland B.V.ELW2026-03-05
08719327516010Cavex CleverCast - Normal SetCavex Holland B.V.ELW2026-03-05
E241AA6050Cavex Cream FastCavex Holland B.V.ELW2026-03-04
E241AA6051Cavex Cream Fast Cavex Holland B.V.ELW2026-03-04
07630243601684AdhesiveDent4You AGELW2026-02-10
07630243601691AdhesiveDent4You AGELW2026-02-10
00850079280427CAvexHexa DentalELW2026-01-22
00850079280014One PlusHexa DentalELW2026-01-21
00085007928014One PlusHexa DentalELW2026-01-21
00850057092240HexaHexa DentalELW2026-01-21
00850057092929One PlusHexa DentalELW2026-01-21
00850057092936One PlusHexa DentalELW2026-01-21
00850057092943One PlusHexa DentalELW2026-01-21
00850057092950One PlusHexa DentalELW2026-01-21
00850057092967One PlusHexa DentalELW2026-01-21
00850057092974One PlusHexa DentalELW2026-01-21
00850057092981One PlusHexa DentalELW2026-01-21
00850079280007One PlusHexa DentalELW2026-01-21
00850079280021One PlusHexa DentalELW2026-01-21
00850079280304CavexHexa DentalELW2026-01-21
00850079280311cAVEXHexa DentalELW2026-01-21
00850079280328CavexHexa DentalELW2026-01-21
00850079280335CavexHexa DentalELW2026-01-21
00850079280342CavexHexa DentalELW2026-01-21
00850079280359CavexHexa DentalELW2026-01-21
00850057092714Hexa DentalHexa DentalELW2026-01-19
00850057092721Hexa dentalHexa DentalELW2026-01-19