SHORT RADIOGRAPHIC DIRECTION INDICATOR
- Primary DI
- 08435389801115
- Brand
- SHORT RADIOGRAPHIC DIRECTION INDICATOR
- Company
- BIOTECHNOLOGY INSTITUTE SL
- Model
- IDCC
- Published
- 2022-11-23
- 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
- false
Product Codes
| Code | Name |
|---|
| EJB | Handle, Instrument, Dental |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EJB | Handle, Instrument, Dental | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08435389801115 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08435389801115 | 08435389801115 | 8435389801115 |
GMDN Terms
| Term | Definition |
|---|
| Dental implantation depth/angle gauge, reusable | A device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 461665312
- Device count
- 1
- DM exempt
- false
- 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
- false
- 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 DI | Brand | Model | Catalog | Published |
|---|
| 08435389828952 | EXTRACTOR FOR IMPLANTS 8 | EXIM8 | | 2026-01-30 |
| 08435389828969 | EXTRACTOR FOR IMPLANTS 9 | EXIM9 | | 2026-01-30 |
| 08435389829027 | SHORT DRILL; Ø2,2 MM | F22CS | | 2026-01-30 |
| 08435389829034 | SHORT DRILL; Ø2,3 MM | F23CS | | 2026-01-30 |
| 08435389829041 | SHORT DRILL; Ø2,4 MM | F24CS | | 2026-01-30 |
| 08435389829058 | SHORT DRILL; Ø2,0 MM | F20CS | | 2026-01-30 |
| 08435389829096 | FLATTENING FRONT CUTTING SHORT DRILL; Ø5.5 | FCFA55C | | 2026-01-30 |
| 08435389830061 | EXTRA SHORT INITIAL DRILL | FIXS | | 2026-01-30 |
| 08435389830078 | EXTRA SHORT DRILL; Ø1,8 MM | F18XS | | 2026-01-30 |
| 08435389830085 | EXTRA SHORT DRILL; Ø1,8/2,5 MM | F1825XS | | 2026-01-30 |
| 08435389830092 | EXTRA SHORT DRILL; Ø2,5 MM | F25XS | | 2026-01-30 |
| 08435389830108 | EXTRA SHORT DRILL; Ø2,8 MM | F28XS | | 2026-01-30 |
| 08435389830115 | EXTRA SHORT DRILL; Ø3 MM | F30XS | | 2026-01-30 |
| 08435389830269 | HEATING OVEN H-PLUS | BTI H-PLUS | | 2026-01-30 |
| 08435389830276 | DRILL HOLDER FOR EXTRA SHORT DRILLS | FFXS | | 2026-01-30 |
| 08435389830320 | SHORT DRILL; Ø1.5 MM | F15CS | | 2026-01-30 |
| 08435389829706 | EXPANDED SQUARE INTERFACE; MULTI-IM ABUTMENT; WIDE PLATFORM | ISMIPAX | | 2026-01-29 |
| 08435389829713 | EXPANDED SQUARE INTERFACE; UNIT ABUTMENT; WIDE PLATFORM | ISMIUPAX | | 2026-01-29 |
| 08435389829843 | MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; Ø3,5; H 4,5MM | INTMIP33545 | | 2026-01-29 |
| 08435389829850 | MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; H 4,5MM | INTMIP345 | | 2026-01-29 |
Other Devices Sharing Product Codes