Manufacturer registered with FDA
Prodont-Holliger
OLLIERGUES, France. Lists 20 dental device types with FDA across 1 registered establishment.
- Device types listed
- 20
- Brands and models
- 126
- 510(k) clearances
- 0as applicant
- Markets registered in
- 895 registrations outside the US
- Establishments
- 1France
Registered in 8 markets
Where regulators' registries name Prodont-Holliger as the manufacturer or the registration holder of a device.
RegisteredHome: FranceOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Prodont-Holliger | 20 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Prodont-Holliger | 45 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Prodont-Holliger | 34 | 2018–2018 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | PRODONT-HOLLIGER S.A.S.PRODONT- HOLLIGER S.A.S · PRODONT HOLLIGER S.A.S | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PRODONT-HOLLIGER S.A.S.PRODONT HOLLIGER S.A.S. | 5 | 2009–2019 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PRODONT HOLLIGER | 3 | 2019–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Prodont-Holliger S.A.S. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Prodont Holliger | 1 | 2017–2017 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Prodont-Holliger currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | CIMENT SPATULA SP10 reference 2469SI - cement spatula sple n 9 BlissCIMENT SPATULA SP24 reference 246.24SI - cement spatula sple SP24 BlissCIMENT SPATULA SP5 reference 2465SI - cement spatula sple n 5 Bliss | 2019 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Article N° 017-24803 - MICRO MIR 7/2 MM REC CS FSArticle N° 7090011 - MP4522 - TI M.MIRRORSArticle N° 7090012 - MP4524 - TI M.MIRRORSArticle N° 7090013 - MPP8524 - DS TI MIRRORSArticle N° 7090030 - MZP511 - TI OCCL MIRRORArticle N° 7090031 - MZP521 - TI OCCL MIRRORArticle N° 7090032 - MZP 531 - TI LING MIRRORArticle N° 7090033 - MZP541 - TI BUCCAL MIRRORArticle N° 7090034 - MZP551 - TI BUCC WIDE MIRRORMIRROR 5 PURE REFLECT reference MP4624PH 13 moreMP4303 - MICRO MIRROR CSS 3 MMMP4305 - MICRO MIRROR CSS 5 MMMP4624NOR-MIRROR PURE REFLECT P5 CSS box of 12MP4624PH - MIRROR PLAN CSS PR5 X12MP4624PHIP - MIROIR P.REFL P5 CSS BTE12 I.PMP7824PH - MIRRORS DOUBLE SIDED PURE REFLECT 5 X12MPP8324PH MIRROR RH PLANE 5 DOUBLE FACEMZP511IP - MIROIR PHOTO TI FACE OCCL I.PMZP512IP - MIROIR PHOTO CHR FACE OCCL I.PMZP516IP - MIROIR PHOTO P.REFLEC FACE I.PMZP531IP - MIROIR PHOTO TI FACE VESTI I.PMZP532IP - MIROIR PHOTO CHR FACE VEST I.PMZP536IP - MIROIR PHOTO P.REFLEC FACE I.P | 1985 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | 410-OTXL INSTR. EXPERIENCE OPEN TOOL XL 50-0030-0000 | 2026 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | 6360TCIP- CISEAUX LAGRANGE 11.5CM TC I.P | 1987 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | Article : PRODONT CUT OFF WHEEL AP3707011Article : PRODONT CUT OFF WHEEL AP3710011Article : PRODONT CUT OFF WHEEL AP3717011Article : PRODONT SPEEDY CUT OFF AP2206011Article : PRODONT SPEEDY DISK AP220202SArticle : PRODONT SPEEDY SEPARATING DISK AP2206020Article : PRODONT SPEEDY SEPARATING DISK CUP AP2206050Article : PRODONT SPEEDY SLIM DISK AP2202612Article : PRODONT SPEEDY SLIM DISK AP2505011SPEEDY DISC | 1984 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | MZP215IP- CONTRAST N4 PETIT MODELE I.PMZP218IP - CONTRAST N1 84MMX85MM I.P233.20IP - CASSET DE CHIRU 285x92x3 I.P233.30 -CASSETTE STERILISATION EASY CL | 2020 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | PERIODONTIC PROBE 23-12-1 reference 4186SI - probe graduations n 6 BlissPERIODONTIC PROBE 23-12-3 reference 4187SI - probe graduations n7 BlissPERIODONTIC PROBE 23-15-1 reference 4188SI - probe graduations n8 BlissPERIODONTIC PROBE 23-15-3 reference 4189SI - probe graduations n9 Bliss4180XLIP - SONDE PARO WILLIAM NF14 XL I.P | 1987 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | MODELLING SPATULA CPR01 reference 194.12SI-modeling instr. bliss n1MODELLING SPATULA CPR02 reference 194.13SI-modeling instr. bliss n2MODELLING SPATULA CPR05 rference 194.16SI-modeling instr. bliss n5MODELLING SPATULA OP55 reference 1925SI-modelling instr. op55 bliss1931XLIP - SPAT DE BOUCHE HEI N1XL I.P | 1987 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | MIRROR HANDLE reference 2120SIMZP214IP - MCHE ARTICULE POUR MIROIRS I.P2100D - MIRROR HANDLE DESIGN SIMPL STEM2120DIP - MCHE MIROIR INOX CSS DESIG I.P2120XL - MIRROR HANDLE CSS XL6100XLIP - MANCHE BISTOURI ROND XL I.P | 1987 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | 2202SIP PRECELLE LISSE N2 SAT I.P | 2020 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | PROBE 11-12 referene 2636SI -probe double 11/12 BlissPROBE 23-17 reference 2637SI -probe double 23/17 Bliss | 1987 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | EXCAVATOR 36EX35 reference 1651SI - excavator dble n 1 BlissEXCAVATOR 38EX37 reference 1652SI -excavator dble n 2 BlissEXCAVATOR EX91 reference 1653SI -excavator dble n 3 Bliss | 1987 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | MODELLING SPATULA CPR03 reference 194.14SI - modeling instr. Bliss n3MODELLING SPATULA CPR03S regerence 194.15SI -modeling instr. Bliss n4 | 1987 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | BRUNISHER 125 reference 108.14SI - brunisher dble N 4 bliss | 1987 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | MACHTOU 1-1 reference 4191SI -burnisher machtou 1-1 blissMACHTOU 1-2 reference 4192SI-burnisher machtou 1-2 blissMACHTOU 2-3 reference 4193SI -burnisher machtou 2-3 blissMACHTOU 2-4 reference 4194SI-burnisher machtou 2-4 bliss | 2019 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | REFERENCE 1290.13 - FORCEPS LOW CANINE/ BICUSPID SATINREFERENCE 1290.18 FORCEPS UP LEFT MOLARS SATINREFERENCE 1290.21 - FORCEPS LOWER MOLARS SATINREFERENCE 1290.22 - FORCEPS LOWER MOLARS SATINREFERENCE 1290.33 - FORCEPS FOR LOWER ROOTS SATINREFERENCE 1290.51 - FORCEPS FOR UPPER ROOTS SATINREFERENCE 1290.73 - FORCEPS LOWER MOLARS SATINREFERENCE 1290.75 - FORCEPS LOW CANINE / BICUSPID SATINREFERENCE 1290.79 - FORCEPS LOWER WISDOMS SATINREFERENCE 12901 - FORCEPS UP CENTRAL / CANINE SATIN 5 moreREFERENCE 12902 - FORCEPS RETENTIV.SATIN 2REFERENCE 12904 - FORCEPS LOW INCISOR/ CANINE SATINREFERENCE 12907 - FORCEPS FOR UP BICUSPIDS SATINREFERENCE 12908 - FORCEPS LOWER BICUSPIDS SATINREFERENCE1290.17 - FORCEPS UP RIGHT MOLARS SATIN | 2020 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | Elevator 149.20Elevator 149.21Elevator 1491Elevator 159.51Elevator 159.53Elevator 159.571491IP - ELEV VIGNAL FORME LANCET I.P1500XLIP- ELEVATEUR SINUS N0 XL I.P1501D - ELEVATEUR SINUS N1 D1501XL- ELEVATEUR SINUS N1 XL 9 more1503XL ELEVATEUR SINUS N3 XL1503XLIP- ELEVATEUR SINUS N3 XL I.P1504XLIP - ELEVATEUR SINUS N4 XL I.P1505XLIP - ELEVATEUR SINUS N5 XL I.P1506XLIP - MINI DECOL DE SINUS N6 XL I.P159.55IP - ELEV MANCHE LEGER A/APPUI I.P4075XLIP - DECOLL ROOS A/MIROIR XL I.P4076XLIP - DECOLL DE PAPILLES MCHE XL I.P4079XLIP - DECOLLEUR MOLT D9 XL I.P | 1987 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | 135.85XLIP - CURETTE LUCAS DBLE N85 XL I.P135.86XLIP- CURETTE LUCAS DBLE N86 XL I.P | 1987 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | H5-L5 reference 4065SI - instr.dble H5-L5 BlissH6-H7 reference 4067SI -instr. dble H6-H7 blissM23 - reference 404.23SI -scaler M23 BlissMICRO CK6 COURBE BLISS- 4045SIN128-L5 MINI reference 4069SI - instr.dble N128-L5 mini BlissN128-L5 reference 4068SI -instr.dble N128-L5 bliss | 2019 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | BARNHART 5-6 reference 4085SI - curette barnhart 5-6 blissCOLUMBIA 4L-4R reference 4054SI - curette columbia 4l-4r blissCURETTE LANGER 5-6 Mini BLISS - 4023SICURETTE LANGER 5-6 Mini BLISS- 406.10SIGRACEY 1-2 reference 4021SI - curette perio db gracey 1/2 blissGRACEY 11-12 reference 402.11SI - curette perio gracey11/12 blissGRACEY 13-14 reference 402.13SI - curette perio db gracey 13/14 blissGRACEY 15-16 reference 402.15SI -curette perio gracey15/16 blissGRACEY 5-6 4025SI - curette perio db gracey 5/6 blissGRACEY17-18 reference 402.17SI - curette perio gracey17/18 bliss 3 moreLANGER 5-6 reference 4066SI - curette langer 5-6 bliss400CSS.SI-KIT PROPHYLAXIE CSS BLISS405.13SI- CURETTE COLUMBIA 13-14 BLISS | 1987 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PRODONT-HOLLIGER S.A.S.FDA reg. 9611899 | OLLIERGUES Puy-de-Dome, France | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8020817). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.